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Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02229864
Recruitment Status : Completed
First Posted : September 3, 2014
Results First Posted : December 14, 2016
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Coronary Artery Disease
Coronary Artery Stenosis
Coronary Disease
Coronary Stenosis
Intervention Device: Coronary artery stenting: Absorb BVS
Enrollment 12
Recruitment Details The first subject was enrolled on June 2, 2014 and the last subject was enrolled on September 17, 2014. The last 30-day follow-up visit occurred on October 14, 2014. Database was locked on Oct 29, 2014. A total of 12 subjects were registered and there had been 2 early terminations from study as on October 4, 2017 (3 years follow-up) due to deaths.
Pre-assignment Details In this sub-study, subjects received either one (N=8) or two (N=4) Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)

Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm

• Scaffold lengths: 8, 12, 18, and 28 mm

Period Title: 1 - Month Visit
Started 12
Completed 12
Not Completed 0
Period Title: 6 - Month Visit
Started 12
Completed 12
Not Completed 0
Period Title: 1 - Year Visit
Started 12
Completed 12
Not Completed 0
Period Title: 2 - Year Visit
Started 12
Completed 11
Not Completed 1
Reason Not Completed
Missed Visits             1
Period Title: 3 - Year Visit
Started 12 [1]
Completed 10
Not Completed 2
Reason Not Completed
Death             2
[1]
The missed visit participant in the 2nd year has joined the study for 3rd year follow-up.
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)

Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm

• Scaffold lengths: 8, 12, 18, and 28 mm

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
The PK sub-study had slightly more male subjects, and slightly more subjects with dyslipidemia and hypertension requiring medication and subjects with stable angina as compared to ABSORB III Primary Analysis Group. The PK sub-study had fewer subjects who had undergone prior coronary intervention.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
60.1  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
1
   8.3%
Male
11
  91.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
 100.0%
Hypertension Requiring Medication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
12
 100.0%
Dyslipidemia Requiring Medication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
12
 100.0%
Prior Coronary Intervention  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
1
   8.3%
Stable Angina  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
9
  75.0%
1.Primary Outcome
Title Maximum Concentration (Cmax)
Hide Description Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: nanograms per milliliter
2.397
(1.085 to 4.460)
2.Primary Outcome
Title Time of Maximum (Tmax)
Hide Description Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: Hours
0.55
(0.17 to 2.37)
3.Primary Outcome
Title AUC24h
Hide Description Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method.
Time Frame 0 to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: ng*h/mL
22.67
(12.09 to 44.22)
4.Primary Outcome
Title AUC Last
Hide Description Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.
Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: ng*h/mL
55.90
(25.37 to 104.6)
5.Primary Outcome
Title AUC 0-infinity
Hide Description

AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).

calculated as: AUC0-∞ = AUClast + (Clast/λz)

The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as:

%AUC0-∞ex = (AUC0-∞ – AUClast)/ AUC0-∞ * 100

Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: ng*h/mL
72.02
(33.15 to 120.8)
6.Primary Outcome
Title Terminal Elimination Rate Constant (λz)
Hide Description The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve.
Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: 1/hour
0.01092
(0.006027 to 0.01511)
7.Primary Outcome
Title Terminal Elimination Half-life (t1/2term)
Hide Description

The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).

calculated as: t1/2term = 0.693/λz.

Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: Hours
63.5
(45.9 to 115.0)
8.Primary Outcome
Title Drug Clearance (CL)
Hide Description

The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).

Calculated as: CL = Dose/AUC0 - ∞ .

Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: Liter/hour
3.451
(2.421 to 5.460)
9.Secondary Outcome
Title Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)
Hide Description Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
Time Frame ≤ 7 days post index procedure (In-hospital )
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
10.Secondary Outcome
Title Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)
Hide Description Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
Time Frame 0 to 37 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
11.Secondary Outcome
Title Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)
Hide Description Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
Time Frame 0 to 208 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
12.Secondary Outcome
Title Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)
Hide Description Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
Time Frame 0 to 393 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
13.Secondary Outcome
Title Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)
Hide Description Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
Time Frame 0 to 758 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
14.Secondary Outcome
Title Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)
Hide Description Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
Time Frame 0 to 1123 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
2
  16.7%
15.Secondary Outcome
Title Number of Subjects With All Death
Hide Description All death includes cardiac death, vascular death, and non-cardiac death.
Time Frame ≤ 7 days post index procedure (In-hospital )
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
16.Secondary Outcome
Title Number of Subjects With All Death
Hide Description All death includes cardiac death, vascular death, and non-cardiac death.
Time Frame 0 to 37 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
17.Secondary Outcome
Title Number of Subjects With All Death
Hide Description All death includes cardiac death, vascular death, and non-cardiac death.
Time Frame 0 to 208 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
18.Secondary Outcome
Title Number of Subjects With All Death
Hide Description All death includes cardiac death, vascular death, and non-cardiac death.
Time Frame 0 to 393 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
19.Secondary Outcome
Title Number of Subjects With All Death
Hide Description All death includes cardiac death, vascular death, and non-cardiac death.
Time Frame 0 to 758 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
20.Secondary Outcome
Title Number of Subjects With All Death
Hide Description All death includes cardiac death, vascular death, and non-cardiac death.
Time Frame 0 to 1123 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
2
  16.7%
21.Secondary Outcome
Title Number of Subjects With All Myocardial Infarction (MI)
Hide Description All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
Time Frame ≤ 7 days post index procedure (In-hospital )
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
22.Secondary Outcome
Title Number of Subjects With All Myocardial Infarction (MI)
Hide Description All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
Time Frame 0 to 37 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
23.Secondary Outcome
Title Number of Subjects With All Myocardial Infarction (MI)
Hide Description All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
Time Frame 0 to 208 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
2
  16.7%
24.Secondary Outcome
Title Number of Subjects With All Myocardial Infarction (MI)
Hide Description All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
Time Frame 0 to 393 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
2
  16.7%
25.Secondary Outcome
Title Number of Subjects With All Myocardial Infarction (MI)
Hide Description All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
Time Frame 0 to 758 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
3
  25.0%
26.Secondary Outcome
Title Number of Subjects With All Myocardial Infarction (MI)
Hide Description All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
Time Frame 0 to 1123 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
4
  33.3%
27.Secondary Outcome
Title Number of Subjects With All Target Lesion Revascularization (TLR)
Hide Description All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
Time Frame ≤ 7 days post index procedure (In-hospital )
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
28.Secondary Outcome
Title Number of Subjects With All Target Lesion Revascularization (TLR)
Hide Description All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
Time Frame 0 to 37 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
29.Secondary Outcome
Title Number of Subjects With All Target Lesion Revascularization (TLR)
Hide Description All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
Time Frame 0 to 208 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
30.Secondary Outcome
Title Number of Subjects With All Target Lesion Revascularization (TLR)
Hide Description All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
Time Frame 0 to 393 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
31.Secondary Outcome
Title Number of Subjects With All Target Lesion Revascularization (TLR)
Hide Description All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
Time Frame 0 to 758 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
32.Secondary Outcome
Title Number of Subjects With All Target Lesion Revascularization (TLR)
Hide Description All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
Time Frame 0 to 1123 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
33.Secondary Outcome
Title Number of Subjects With All Target Vessel Revascularization (TVR)
Hide Description All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
Time Frame ≤ 7 days post index procedure (In-hospital )
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
34.Secondary Outcome
Title Number of Subjects With All Target Vessel Revascularization (TVR)
Hide Description All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
Time Frame 0 to 37 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
35.Secondary Outcome
Title Number of Subjects With All Target Vessel Revascularization (TVR)
Hide Description All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
Time Frame 0 to 208 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
36.Secondary Outcome
Title Number of Subjects With All Target Vessel Revascularization (TVR)
Hide Description All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
Time Frame 0 to 393 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
37.Secondary Outcome
Title Number of Subjects With All Target Vessel Revascularization (TVR)
Hide Description All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
Time Frame 0 to 758 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
38.Secondary Outcome
Title Number of Subjects With All Target Vessel Revascularization (TVR)
Hide Description All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
Time Frame 0 to 1123 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
39.Secondary Outcome
Title Number of Subjects With All Revascularization
Hide Description All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
Time Frame ≤ 7 days post index procedure (In-hospital )
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
40.Secondary Outcome
Title Number of Subjects With All Revascularization
Hide Description All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
Time Frame 0 to 37 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
41.Secondary Outcome
Title Number of Subjects With All Revascularization
Hide Description All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
Time Frame 0 to 208 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
2
  16.7%
42.Secondary Outcome
Title Number of Subjects With All Revascularization
Hide Description All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
Time Frame 0 to 393 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
2
  16.7%
43.Secondary Outcome
Title Number of Subjects With All Revascularization
Hide Description All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
Time Frame 0 to 758 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
3
  25.0%
44.Secondary Outcome
Title Number of Subjects With All Revascularization
Hide Description All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
Time Frame 0 to 1123 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
3
  25.0%
45.Secondary Outcome
Title Number of Subjects With Acute Stent/Scaffold Thrombosis (Definite/Probable)
Hide Description

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timings:

Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation

Time Frame ≤ 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
46.Secondary Outcome
Title Number of Subjects With Subacute Stent/Scaffold Thrombosis (Definite/Probable)
Hide Description

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timings:

Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation

Time Frame >1 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
47.Secondary Outcome
Title Number of Subjects With Late Stent/Scaffold Thrombosis (Definite/Probable)
Hide Description

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timings:

Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation

Time Frame 31 to 393 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
48.Secondary Outcome
Title Number of Subjects With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)
Hide Description

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timings:

Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation

Time Frame 0 to 393 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
49.Secondary Outcome
Title Number of Subjects With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)
Hide Description

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.

Timings:

Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation

Time Frame 0 to 1123 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description:

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).

Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Coronary Artery Stenting: Absorb BVS
Hide Arm/Group Description

Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)

Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm

• Scaffold lengths: 8, 12, 18, and 28 mm

All-Cause Mortality
Coronary Artery Stenting: Absorb BVS
Affected / at Risk (%)
Total   2/12 (16.67%) 
Show Serious Adverse Events Hide Serious Adverse Events
Coronary Artery Stenting: Absorb BVS
Affected / at Risk (%)
Total   9/12 (75.00%) 
Cardiac disorders   
Angina Pectoris  1  2/12 (16.67%) 
Atrial Fibrillation  1  1/12 (8.33%) 
Acute Myocardial Infarction  1  1/12 (8.33%) 
Unstable Angina  1  1/12 (8.33%) 
Gastrointestinal disorders   
Small Intestinal Obstruction  1  1/12 (8.33%) 
Upper Gastrointestinal Haemorrhage  1  1/12 (8.33%) 
General disorders   
Chest Pain  1  1/12 (8.33%) 
Chest Pain (Non-Cardiac)  1  1/12 (8.33%) 
Infections and infestations   
Cellulitis  1  2/12 (16.67%) 
Sepsis  1  1/12 (8.33%) 
Injury, poisoning and procedural complications   
Coronary Artery Restenosis  1  1/12 (8.33%) 
Spinal Compression Fracture  1  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders   
Lumbar Spinal Stenosis  1  3/12 (25.00%) 
Painful in Extremity  1  1/12 (8.33%) 
Renal and urinary disorders   
Acute Renal Failure  1  1/12 (8.33%) 
Reproductive system and breast disorders   
Benign Prostatic Hyperplasia  1  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary Oedema  1  1/12 (8.33%) 
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Coronary Artery Stenting: Absorb BVS
Affected / at Risk (%)
Total   12/12 (100.00%) 
Cardiac disorders   
Angina Pectoris  1  3/12 (25.00%) 
Bradycardia  1  1/12 (8.33%) 
Congestive Heart Failure  1  1/12 (8.33%) 
Coronary Artery Dissection  1  3/12 (25.00%) 
Coronary No-Reflow Phenomenon  1  1/12 (8.33%) 
Gastrointestinal disorders   
Dyspepsia  1  1/12 (8.33%) 
Toothache  1  1/12 (8.33%) 
General disorders   
Chest Pain (Non-Cardiac)  1  2/12 (16.67%) 
Infusion Site Hematoma  1  1/12 (8.33%) 
Infections and infestations   
Bronchitis  1  1/12 (8.33%) 
Injury, poisoning and procedural complications   
Arthropod Bite  1  1/12 (8.33%) 
Post Procedural Myocardial Infarction  1  1/12 (8.33%) 
Procedural Hypotension  1  1/12 (8.33%) 
Contusion  1  1/12 (8.33%) 
Urinary Retention Postoperative  1  1/12 (8.33%) 
Investigations   
Cardiac Enzymes Increased  1  2/12 (16.67%) 
Blood Creatine Phosphokinase MB Increased  1  3/12 (25.00%) 
Musculoskeletal and connective tissue disorders   
Back Pain  1  1/12 (8.33%) 
Costochondritis  1  1/12 (8.33%) 
Monoarthritis  1  1/12 (8.33%) 
Musculoskeletal Chest Pain  1  1/12 (8.33%) 
Nervous system disorders   
Dizziness  1  1/12 (8.33%) 
Sciatica  1  1/12 (8.33%) 
Renal and urinary disorders   
Urinary Retention  1  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Hypoxia  1  1/12 (8.33%) 
Sleep Apnoea Syndrome  1  1/12 (8.33%) 
Dyspnoea  1  1/12 (8.33%) 
Vascular disorders   
Deep Vein Thrombosis  1  1/12 (8.33%) 
Reperfusion Injury  1  1/12 (8.33%) 
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Principal Investigators shall not present or publish, nor submit for publication, any work resulting from the Services without Sponsor’s prior written approval.

Except as specifically set forth herein, neither party shall use the other party’s name or trademark, or the name nor trademark of such other party’s affiliate, in any publicity, advertising or announcement, or disclose the existence or terms of this Agreement, without the consenting party’s prior written approval.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Latania Chura
Organization: Abbott Vascular
Phone: 503-935-3002
EMail: latania.chura@abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02229864     History of Changes
Other Study ID Numbers: 10-392 B
First Submitted: June 9, 2014
First Posted: September 3, 2014
Results First Submitted: May 23, 2016
Results First Posted: December 14, 2016
Last Update Posted: November 22, 2019