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Absorb GT1 Japan PMS

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: NCT03409731
Recruitment Status : Active, not recruiting
First Posted : January 24, 2018
Results First Posted : January 3, 2019
Last Update Posted : January 3, 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: Prevention
Conditions Ischemic Heart Disease
Angina Pectoris
Coronary Artery Disease
Coronary Artery Occlusion
Myocardial Ischemia
Intervention Device: ABSORB GT1 BVS
Enrollment 135
Recruitment Details This Post-marketing Surveillance study was conducted in patients with ischemic heart disease potentially indicated for treatment with the Absorb GT1 Bioresorbable Vascular Scaffold System. A total of 135 patients were enrolled between December 13, 2016 to December 11, 2017 time period.
Pre-assignment Details The proposed target sample size of the surveillance was approximately 2,000 patients. However, only 135 patients were registered in this study since Absorb GT1 was withdrawn from global market, due to low sales volume
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Period Title: Overall Study
Started 135
Completed 135
Not Completed 0
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Baseline Participants 135
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 135 participants
64.0  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants
Female
21
  15.6%
Male
114
  84.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
135
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
135
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 135 participants
135
Diabetes Mellitus  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants
53
  39.3%
Dyslipidemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants
93
  68.9%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants
103
  76.3%
Estimated Glomerular Filtration Rate (eGFR)  
Mean (Standard Deviation)
Unit of measure:  Ml/min/1.73m^2
Number Analyzed 135 participants
58.25  (25.15)
Previous Myocardial Infarction (MI)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants
13
   9.6%
Prior PCI  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants
35
  25.9%
1.Primary Outcome
Title Number of Participants With Acute Scaffold Thrombosis (ST)
Hide Description

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%).

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 Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Number
Unit of Measure: participants
Definite 0
Probable 0
Definite/Probable 0
2.Primary Outcome
Title Number of Participants With Sub Acute Scaffold Thrombosis (ST)
Hide Description

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%).

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
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Number
Unit of Measure: participants
Definite 0
Probable 0
Definite/Probable 0
3.Primary Outcome
Title Number of Participants With Late Scaffold Thrombosis (ST)
Hide Description

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). 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 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Number
Unit of Measure: participants
Definite 0
Probable 0
Definite/Probable 0
4.Primary Outcome
Title Number of Participants With Cumulative Scaffold Thrombosis
Hide Description

Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%).

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 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Number
Unit of Measure: participants
Definite 0
Probable 0
Definite/Probable 0
5.Primary Outcome
Title Number of Participants With Composite of Device Deficiencies
Hide Description

Device deficiencies: Number of participants with at least one of the following Device deficiencies

  1. Lesion/implant failure
  2. Delivery difficulty (finally delivered)
  3. Re-crossing failure
  4. Re-crossing difficulty
  5. Post-dilatation balloon
  6. Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS)
  7. Instruction for Use (IFU) not included
  8. Major Strut Malapposition
  9. Strut Fracture within 6 months
Time Frame During index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
Lesion/implant failure
0
   0.0%
Delivery difficulty (finally delivered)
6
   4.4%
Re-crossing failure
1
   0.7%
Re-crossing difficulty
0
   0.0%
Post-dilatation balloon+OCT/IVUS
11
   8.1%
IFU not included
1
   0.7%
Major Strut Malapposition
1
   0.7%
Strut Fracture within 6 months
1
   0.7%
6.Secondary Outcome
Title Number of Cardiac Death/Myocardial Infarction (MI)
Hide Description Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
7.Secondary Outcome
Title Number of Cardiac Death/Myocardial Infarction (MI)
Hide Description Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 0 to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
8.Secondary Outcome
Title Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Hide Description

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
9.Secondary Outcome
Title Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Hide Description

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame 0 to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
10.Secondary Outcome
Title Number of Cardiac Death
Hide Description Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment
Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
11.Secondary Outcome
Title Number of Cardiac Death
Hide Description Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time Frame 0 to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
12.Secondary Outcome
Title Number of Participants With All Myocardial Infarction (MI)
Hide Description

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)

Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
13.Secondary Outcome
Title Number of Participants With All Myocardial Infarction (MI)
Hide Description

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)

Time Frame 0 to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
14.Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Hide Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
15.Secondary Outcome
Title Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Hide Description Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Time Frame 0 to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
16.Secondary Outcome
Title Number of Participants With All Target Lesion Revascularization (TLR)
Hide Description

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.7%
17.Secondary Outcome
Title Number of Participants With All Target Lesion Revascularization (TLR)
Hide Description

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Time Frame 0 to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.7%
18.Secondary Outcome
Title Number of Participants With Ischemic-Driven Target Lesion Revascularization (ID-TLR)
Hide Description

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
19.Secondary Outcome
Title Number of Participants With Ischemic-Driven Target Lesion Revascularization (ID-TLR)
Hide Description

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Time Frame 0 to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
20.Secondary Outcome
Title Number of Participants With All Target Vessel Revascularization (TVR)
Hide Description Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.7%
21.Secondary Outcome
Title Number of Participants With All Target Vessel Revascularization (TVR)
Hide Description Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame 0 to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.7%
22.Secondary Outcome
Title Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Hide Description Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
23.Secondary Outcome
Title Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Hide Description Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame 0 to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
24.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Coronary revascularization attributed to either Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)
Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.7%
25.Secondary Outcome
Title Number of Participants With All Coronary Revascularization
Hide Description Coronary revascularization attributed to either Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)
Time Frame 0 to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.7%
26.Secondary Outcome
Title Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
27.Secondary Outcome
Title Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Hide Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 0 to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
28.Secondary Outcome
Title Number of Death/MI/All Revascularization (DMR)
Hide Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.7%
29.Secondary Outcome
Title Number of Death/MI/Any Revascularization (DMR)
Hide Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame 0 to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants with Absorb GT1)
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.7%
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Absorb GT1 BVS
Hide Arm/Group Description Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
All-Cause Mortality
Absorb GT1 BVS
Affected / at Risk (%)
Total   0/135 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Absorb GT1 BVS
Affected / at Risk (%)
Total   4/135 (2.96%) 
Hepatobiliary disorders   
CHOLECYSTITIS  1  1/135 (0.74%) 
GALLSTONE ATTACK  1  1/135 (0.74%) 
Injury, poisoning and procedural complications   
LUNG CONTUSION  1  1/135 (0.74%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
CANCER OF HEAD OF PANCREAS  1  1/135 (0.74%) 
1
Term from vocabulary, MedDRA 11.0
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%
Absorb GT1 BVS
Affected / at Risk (%)
Total   2/135 (1.48%) 
Skin and subcutaneous tissue disorders   
DRUG ERUPTION  1  1/135 (0.74%) 
Surgical and medical procedures   
TLR  1  1/135 (0.74%) 
1
Term from vocabulary, MedDRA 11.0
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.
Results Point of Contact
Name/Title: Hajime Kusano
Organization: Abbott medical device
Phone: +1 408-845-1626
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03409731     History of Changes
Other Study ID Numbers: 16-310
First Submitted: May 18, 2017
First Posted: January 24, 2018
Results First Submitted: December 7, 2018
Results First Posted: January 3, 2019
Last Update Posted: January 3, 2019