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Trial record 53 of 507 for:    ASPIRIN AND P2

PROMUS Element Plus US Post-Approval Study

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: NCT01589978
Recruitment Status : Completed
First Posted : May 2, 2012
Results First Posted : May 3, 2016
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Interventions Device: PROMUS Element Plus Coronary Stent System
Drug: Aspirin
Drug: P2Y12 antagonist
Enrollment 2681
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PROMUS Element Overall Population
Hide Arm/Group Description

Subjects who receive the PROMUS Element everolimus-eluting coronary stent.

Subgroups within the Overall Population Group:

PLATINUM-Like Patients N=776 (at time of Primary endpoint)

Defined as: all patients without acute MI, graft stenting, CTO, ISR, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate or severe calcification by visual estimate in target lesion or target vessel proximal to target lesion, three-vessel stenting, cardiogenic shock, left main disease, or acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or patient on dialysis). For PLATINUM-like patients, lesion length and RVD should meet one of two criteria: 1) lesion length ≤28 mm and diameter ≥2.25 mm and <2.5 mm, or 2) lesion length ≤24 mm and diameter ≥2.5 mm and ≤4.25 mm.

Long Lesion Patients N=340 Defined as: patients treated with at least one 32mm or 38mm (excluding patients only treated with 2.25 mm diameter and 32 mm length WH stent size) study stent.

Period Title: Overall Study
Started 2681
Completed 2681
Not Completed 0
Arm/Group Title PROMUS Element
Hide Arm/Group Description Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Baseline Participants 2681
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2681 participants
63.7  (11.1)
[1]
Measure Description: Collected as part of a medical history during subject enrollment.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2681 participants
Female
807
  30.1%
Male
1874
  69.9%
[1]
Measure Description: Collected during subject enrollment.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2681 participants
2681
Cardiac History   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2681 participants
History of CAD 1625
History of MI 1409
History of CHF 275
Stable Angina 620
Unstable Angina 1347
Silent Ischemia 149
History of PCI 1159
History of CABG 457
[1]
Measure Description:

Note: A single participant could potentially experience multiple categories listed below.

Collected as part of a medical history during subject enrollment.

Cardiac Risk Factors   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2681 participants
Smoking, Ever 1600
Current Diabetic Mellitus 989
Hyperlipidemia Requiring Medication 2016
History of Hypertension Requiring Medication 2077
Family History of CAD 1625
[1]
Measure Description:

Note: A single participant could potentially experience multiple categories listed below.

Collected as part of a medical history during subject enrollment.

Lesion Characteristics: Target Lesion Vessel   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 2681 participants
Left Anterior Descending Artery 1339
Circumflex Artery 848
Right Coronary Artery 1165
Left Main 54
Graft 199
[1]
Measure Description:

Note: A single participant could potentially experience multiple categories listed below.

Site reported information collected post-enrollment from medical records.

Lesion Characteristics: Lesion Length   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 2681 participants
17.0  (10.3)
[1]
Measure Description: Site reported information collected post-enrollment from medical records.
Lesion Characteristics: Reference Vessel Diameter   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 2681 participants
2.94  (0.51)
[1]
Measure Description: Site reported information collected post-enrollment from medical records.
Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Invarction (TIMI) Flow   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 2681 participants
0 359
1 157
2 487
3 2539
[1]
Measure Description:

Note: A single participant could potentially experience multiple categories listed below.

Site reported information collected post-enrollment from medical records. Stages range from TIMI 0 (no perfusion) to TIMI 3 (normal flow).

TIMI: Thrombolysis in Myocardial Infarction

1.Primary Outcome
Title Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients
Hide Description Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module.
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 1907
Measure Type: Number
Unit of Measure: percentage of patients
1.78
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PROMUS Element
Comments One-sided, single binomial test will be performed to compare observed rate against performance goal, the normal approximation of the test statistic will be used. The performance goal is met if the one-sided upper 95% confidence bound for the observed binary rate is less than performance goal.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Given the performance goal of 3.2%, with expected rate for PROMUS Element Plus of 2.2% and a one-sided 5% significance level, approximately 1,706 PLATINUM-like patients will provide at least 80% power to reject the null hypothesis if it is false.
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients
Hide Description ARC definite/probable ST rate in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if the annual ST rate increase after the first year meets the performance goal (1.0%)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
PROMUS Element PLATINUM-Like patients (a subgroup of the overall population as described in the Participant Flow Module), N=776.
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 776
Measure Type: Number
Unit of Measure: percentage of patients
0.3
3.Secondary Outcome
Title Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients
Hide Description DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)
Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2681
Measure Type: Number
Unit of Measure: percentage of patients
0.7
4.Secondary Outcome
Title Rate of Longitudinal Stent Deformation
Hide Description Compression/elongation of a stent along its long axis resulting from interaction with an ancillary device (e.g., guide catheter) which catches the stent end or an internal stent strut; can occur with advancement or withdrawal of ancillary device. Under fluoroscopy, longitudinal compression usually results in increased strut density and elongation in decreased strut density ('pseudo-fracture'); both can occur in the same stent.
Time Frame Index Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2681
Measure Type: Number
Unit of Measure: stents
2
5.Secondary Outcome
Title Major Adverse Cardiac Event Rate (MACE)
Hide Description Composite of cardiac death, myocardial infarction, and target vessel revascularization
Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
6.9
6.Secondary Outcome
Title Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent
Hide Description Composite of cardiac death, myocardial infarction, and target vessel revascularization related to the PROMUS Element stent
Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
4.7
7.Secondary Outcome
Title Myocardial Infarction (MI) Rate
Hide Description New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN
Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
1.1
8.Secondary Outcome
Title Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent
Hide Description New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN
Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
0.7
9.Secondary Outcome
Title Cardiac Death Rate
Hide Description Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded
Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
1.4
10.Secondary Outcome
Title Rate of Cardiac Death Events Related to the PROMUS Element Stent
Hide Description Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded
Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
1.3
11.Secondary Outcome
Title Target Vessel Revascularization (TVR) Rate
Hide Description Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.
Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
5.6
12.Secondary Outcome
Title Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent
Hide Description Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.
Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
3.5
13.Secondary Outcome
Title Cardiac Death or Myocardial Infarction (MI) Rate
Hide Description See individual descriptions of events.
Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
2.3
14.Secondary Outcome
Title Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent
Hide Description See individual descriptions of events.
Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
1.8
15.Secondary Outcome
Title Target Vessel Failure (TVF) Rate
Hide Description

Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.

For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF.

Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
6.7
16.Secondary Outcome
Title Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent
Hide Description

Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.

For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF.

Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
4.7
17.Secondary Outcome
Title All Death Rate
Hide Description All death includes cardiac death and non-cardiac death.
Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
2.3
18.Secondary Outcome
Title Non-cardiac Death Rate
Hide Description

Non-cardiac death is defined as death not due to cardiac causes.

Cardiac death is death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded.

Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
0.9
19.Secondary Outcome
Title All Death or Myocardial Infarction Rate
Hide Description See description of individual events.
Time Frame ≤24 hours, 30 days, 180 days, annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 2554
Measure Type: Number
Unit of Measure: percentage of patients
3.2
20.Secondary Outcome
Title Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients
Hide Description Any revascularization of the target vessel, myocardial infarction related to the target vessel, or death related to the target vessel. See individual components for descriptions. Statistical testing will determine if the rate meets the performance goal (12.6%)
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Number of Participants Analyzed 276
Measure Type: Number
Unit of Measure: percentage of patients
3.26
21.Secondary Outcome
Title ARC ST Rate in PLATINUM-like Population.
Hide Description Using the Academic Research Consortium (ARC) definition, the (definite/probable) stent thrombosis (ST) rate in the PLATINUM-like* population will be analyzed. Statistical testing will be used to determine if the annual increase after the first year in ST rates observed in PLATINUM-like patients meets the performance goal of 1.0% (expected rate of 0.4% + a delta of 0.6%).
Time Frame Annually through 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module.
Arm/Group Title PROMUS Element Overall Population
Hide Arm/Group Description:
Subjects who receive the PROMUS Element everolimus-eluting coronary stent.
Overall Number of Participants Analyzed 1907
Measure Type: Number
Unit of Measure: percentage of participants
0.0023
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PROMUS Element Overall Population
Comments The expected annual increase of stent thrombosis rate is assumed to be 0.4%, based on the observed increase in incidence rate of stent thrombosis of approximately 0.4% annually for PLATINUM-like patients in the pooled TAXUS SR Express and pooled TAXUS Liberté data. Using a delta of 0.6%, the performance goal is set to 1.0% (expected rate + delta = 0.4% + 0.6% = 1.0%).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The sample size is calculated for one-sample chi-square test for a single proportion using nQuery AdvisorVersion 5.0. The expected annual increase in ST rate is estimated to be 0.4% based on the current data available from the pooled TAXUS Express and pooled TAXUS Liberté data and the PG is 1.0% using a delta of 0.6%. Given a one-sided 5% significance level, a minimum of 1,660 PLATINUM-like patients at 5-yrs will be required to provide 90% power to reject the null hypothesis if it is false.
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PROMUS Element
Hide Arm/Group Description Subjects who receive the PROMUS Element everolimus-eluting coronary stent
All-Cause Mortality
PROMUS Element
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PROMUS Element
Affected / at Risk (%)
Total   780/2681 (29.09%) 
Blood and lymphatic system disorders   
ANAEMIA  1  11/2681 (0.41%) 
HAEMORRHAGIC ANAEMIA  1  6/2681 (0.22%) 
LEUKOCYTOSIS  1  2/2681 (0.07%) 
THROMBOCYTOPENIA  1  2/2681 (0.07%) 
BONE MARROW FAILURE  1  1/2681 (0.04%) 
FEBRILE NEUTROPENIA  1  1/2681 (0.04%) 
IRON DEFICIENCY ANAEMIA  1  1/2681 (0.04%) 
MICROCYTIC ANAEMIA  1  1/2681 (0.04%) 
PANCYTOPENIA  1  1/2681 (0.04%) 
SPONTANEOUS HAEMATOMA  1  1/2681 (0.04%) 
Cardiac disorders   
ANGINA PECTORIS  1  120/2681 (4.48%) 
ANGINA UNSTABLE  1  93/2681 (3.47%) 
CORONARY ARTERY DISEASE  1  49/2681 (1.83%) 
CARDIAC FAILURE CONGESTIVE  1  46/2681 (1.72%) 
ACUTE MYOCARDIAL INFARCTION  1  33/2681 (1.23%) 
MYOCARDIAL INFARCTION  1  22/2681 (0.82%) 
ATRIAL FIBRILLATION  1  23/2681 (0.86%) 
CORONARY ARTERY DISSECTION  1  19/2681 (0.71%) 
CORONARY ARTERY THROMBOSIS  1  15/2681 (0.56%) 
ACUTE CORONARY SYNDROME  1  10/2681 (0.37%) 
ISCHAEMIC CARDIOMYOPATHY  1  10/2681 (0.37%) 
VENTRICULAR TACHYCARDIA  1  8/2681 (0.30%) 
CARDIO-RESPIRATORY ARREST  1  7/2681 (0.26%) 
CORONARY ARTERY STENOSIS  1  7/2681 (0.26%) 
CARDIOMYOPATHY  1  6/2681 (0.22%) 
CARDIAC ARREST  1  5/2681 (0.19%) 
CARDIAC FAILURE CHRONIC  1  5/2681 (0.19%) 
CARDIOGENIC SHOCK  1  4/2681 (0.15%) 
ATRIAL FLUTTER  1  3/2681 (0.11%) 
ATRIOVENTRICULAR BLOCK COMPLETE  1  3/2681 (0.11%) 
CORONARY ARTERY OCCLUSION  1  2/2681 (0.07%) 
MYOCARDIAL ISCHAEMIA  1  3/2681 (0.11%) 
VENTRICULAR FIBRILLATION  1  3/2681 (0.11%) 
CARDIAC FAILURE  1  2/2681 (0.07%) 
MITRAL VALVE INCOMPETENCE  1  2/2681 (0.07%) 
POSTINFARCTION ANGINA  1  2/2681 (0.07%) 
SINUS BRADYCARDIA  1  2/2681 (0.07%) 
TACHYCARDIA  1  2/2681 (0.07%) 
AORTIC VALVE STENOSIS  1  1/2681 (0.04%) 
ARRHYTHMIA  1  1/2681 (0.04%) 
ATRIOVENTRICULAR BLOCK SECOND DEGREE  1  1/2681 (0.04%) 
BRADYCARDIA  1  1/2681 (0.04%) 
BUNDLE BRANCH BLOCK LEFT  1  1/2681 (0.04%) 
CORONARY ARTERY EMBOLISM  1  1/2681 (0.04%) 
HYPERTROPHIC CARDIOMYOPATHY  1  1/2681 (0.04%) 
PALPITATIONS  1  1/2681 (0.04%) 
SICK SINUS SYNDROME  1  1/2681 (0.04%) 
SINUS ARRHYTHMIA  1  1/2681 (0.04%) 
TACHYARRHYTHMIA  1  1/2681 (0.04%) 
Congenital, familial and genetic disorders   
DIVERTICULITIS MECKEL'S  1  1/2681 (0.04%) 
Ear and labyrinth disorders   
VERTIGO  1  3/2681 (0.11%) 
Eye disorders   
CATARACT  1  1/2681 (0.04%) 
Gastrointestinal disorders   
GASTROINTESTINAL HAEMORRHAGE  1  15/2681 (0.56%) 
UPPER GASTROINTESTINAL HAEMORRHAGE  1  8/2681 (0.30%) 
ABDOMINAL PAIN  1  5/2681 (0.19%) 
DYSPHAGIA  1  5/2681 (0.19%) 
RETROPERITONEAL HAEMORRHAGE  1  5/2681 (0.19%) 
COLITIS  1  4/2681 (0.15%) 
DIARRHOEA  1  4/2681 (0.15%) 
GASTRIC ULCER  1  4/2681 (0.15%) 
SMALL INTESTINAL OBSTRUCTION  1  4/2681 (0.15%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  3/2681 (0.11%) 
MELAENA  1  3/2681 (0.11%) 
PANCREATITIS  1  3/2681 (0.11%) 
ABDOMINAL HERNIA  1  2/2681 (0.07%) 
COLITIS ISCHAEMIC  1  2/2681 (0.07%) 
DIABETIC GASTROPARESIS  1  2/2681 (0.07%) 
GASTRITIS  1  2/2681 (0.07%) 
GASTRITIS EROSIVE  1  2/2681 (0.07%) 
INGUINAL HERNIA  1  2/2681 (0.07%) 
LOWER GASTROINTESTINAL HAEMORRHAGE  1  2/2681 (0.07%) 
PANCREATITIS ACUTE  1  2/2681 (0.07%) 
RETROPERITONEAL HAEMATOMA  1  2/2681 (0.07%) 
ANAL FISTULA  1  1/2681 (0.04%) 
DUODENAL ULCER  1  1/2681 (0.04%) 
GASTRIC DISORDER  1  1/2681 (0.04%) 
GASTRIC HAEMORRHAGE  1  1/2681 (0.04%) 
GASTRIC POLYPS  1  1/2681 (0.04%) 
GASTROINTESTINAL PAIN  1  1/2681 (0.04%) 
HAEMATOCHEZIA  1  1/2681 (0.04%) 
HAEMORRHOIDAL HAEMORRHAGE  1  1/2681 (0.04%) 
HAEMORRHOIDS  1  1/2681 (0.04%) 
IMPAIRED GASTRIC EMPTYING  1  1/2681 (0.04%) 
INTESTINAL HAEMORRHAGE  1  1/2681 (0.04%) 
INTESTINAL POLYP  1  1/2681 (0.04%) 
NAUSEA  1  1/2681 (0.04%) 
ODYNOPHAGIA  1  1/2681 (0.04%) 
OESOPHAGEAL ULCER  1  1/2681 (0.04%) 
RECTAL HAEMORRHAGE  1  1/2681 (0.04%) 
VOMITING  1  1/2681 (0.04%) 
General disorders   
NON-CARDIAC CHEST PAIN  1  78/2681 (2.91%) 
DEATH  1  9/2681 (0.34%) 
CHEST PAIN  1  8/2681 (0.30%) 
ASTHENIA  1  4/2681 (0.15%) 
CHEST DISCOMFORT  1  4/2681 (0.15%) 
INFLUENZA LIKE ILLNESS  1  2/2681 (0.07%) 
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME  1  2/2681 (0.07%) 
ULCER HAEMORRHAGE  1  2/2681 (0.07%) 
ADVERSE EVENT  1  1/2681 (0.04%) 
BLOODY DISCHARGE  1  1/2681 (0.04%) 
CATHETER SITE HAEMATOMA  1  1/2681 (0.04%) 
HERNIA  1  1/2681 (0.04%) 
IMPAIRED HEALING  1  1/2681 (0.04%) 
MALAISE  1  1/2681 (0.04%) 
OEDEMA PERIPHERAL  1  1/2681 (0.04%) 
PAIN  1  1/2681 (0.04%) 
PYREXIA  1  1/2681 (0.04%) 
Hepatobiliary disorders   
CHOLELITHIASIS  1  4/2681 (0.15%) 
CHOLECYSTITIS  1  3/2681 (0.11%) 
GALLBLADDER DISORDER  1  2/2681 (0.07%) 
BILIARY DYSKINESIA  1  1/2681 (0.04%) 
CHOLANGITIS  1  1/2681 (0.04%) 
CHOLECYSTITIS ACUTE  1  1/2681 (0.04%) 
CHOLECYSTITIS CHRONIC  1  1/2681 (0.04%) 
HEPATIC CIRRHOSIS  1  1/2681 (0.04%) 
ISCHAEMIC HEPATITIS  1  1/2681 (0.04%) 
Immune system disorders   
DRUG HYPERSENSITIVITY  1  1/2681 (0.04%) 
HYPERSENSITIVITY  1  1/2681 (0.04%) 
Infections and infestations   
PNEUMONIA  1  36/2681 (1.34%) 
CELLULITIS  1  9/2681 (0.34%) 
SEPSIS  1  8/2681 (0.30%) 
URINARY TRACT INFECTION  1  8/2681 (0.30%) 
OSTEOMYELITIS  1  6/2681 (0.22%) 
BRONCHITIS  1  5/2681 (0.19%) 
UROSEPSIS  1  4/2681 (0.15%) 
APPENDICITIS  1  3/2681 (0.11%) 
BACTERAEMIA  1  3/2681 (0.11%) 
DIVERTICULITIS  1  3/2681 (0.11%) 
INFLUENZA  1  3/2681 (0.11%) 
STAPHYLOCOCCAL INFECTION  1  3/2681 (0.11%) 
ABSCESS LIMB  1  2/2681 (0.07%) 
BRONCHIECTASIS  1  2/2681 (0.07%) 
GANGRENE  1  2/2681 (0.07%) 
GASTROENTERITIS VIRAL  1  2/2681 (0.07%) 
INFECTION  1  2/2681 (0.07%) 
LOBAR PNEUMONIA  1  2/2681 (0.07%) 
WOUND INFECTION  1  2/2681 (0.07%) 
ABDOMINAL ABSCESS  1  1/2681 (0.04%) 
ANOGENITAL WARTS  1  1/2681 (0.04%) 
BRONCHITIS VIRAL  1  1/2681 (0.04%) 
CLOSTRIDIAL INFECTION  1  1/2681 (0.04%) 
ENDOCARDITIS BACTERIAL  1  1/2681 (0.04%) 
GASTROENTERITIS  1  1/2681 (0.04%) 
MYCOBACTERIAL INFECTION  1  1/2681 (0.04%) 
OSTEOMYELITIS ACUTE  1  1/2681 (0.04%) 
OSTEOMYELITIS CHRONIC  1  1/2681 (0.04%) 
PNEUMONIA BACTERIAL  1  1/2681 (0.04%) 
PNEUMONIA STAPHYLOCOCCAL  1  1/2681 (0.04%) 
POSTOPERATIVE WOUND INFECTION  1  1/2681 (0.04%) 
PURULENT DISCHARGE  1  1/2681 (0.04%) 
PYELONEPHRITIS  1  1/2681 (0.04%) 
RESPIRATORY TRACT INFECTION  1  1/2681 (0.04%) 
SEPTIC SHOCK  1  1/2681 (0.04%) 
STREPTOCOCCAL BACTERAEMIA  1  1/2681 (0.04%) 
Injury, poisoning and procedural complications   
VASCULAR PSEUDOANEURYSM  1  5/2681 (0.19%) 
HIP FRACTURE  1  4/2681 (0.15%) 
ANKLE FRACTURE  1  2/2681 (0.07%) 
CONTRAST MEDIA REACTION  1  2/2681 (0.07%) 
DRUG TOXICITY  1  2/2681 (0.07%) 
FALL  1  2/2681 (0.07%) 
GRAFT THROMBOSIS  1  2/2681 (0.07%) 
INCISIONAL HERNIA  1  2/2681 (0.07%) 
PELVIC FRACTURE  1  2/2681 (0.07%) 
POST PROCEDURAL COMPLICATION  1  2/2681 (0.07%) 
RIB FRACTURE  1  2/2681 (0.07%) 
ALCOHOL POISONING  1  1/2681 (0.04%) 
ANASTOMOTIC ULCER HAEMORRHAGE  1  1/2681 (0.04%) 
CERVICAL VERTEBRAL FRACTURE  1  1/2681 (0.04%) 
CONCUSSION  1  1/2681 (0.04%) 
DISLOCATION OF JOINT PROSTHESIS  1  1/2681 (0.04%) 
FACIAL BONES FRACTURE  1  1/2681 (0.04%) 
FEMUR FRACTURE  1  1/2681 (0.04%) 
GASTROINTESTINAL STOMA COMPLICATION  1  1/2681 (0.04%) 
GUN SHOT WOUND  1  1/2681 (0.04%) 
POST PROCEDURAL HAEMORRHAGE  1  1/2681 (0.04%) 
POSTOPERATIVE WOUND COMPLICATION  1  1/2681 (0.04%) 
PROCEDURAL HYPERTENSION  1  1/2681 (0.04%) 
PROCEDURAL PAIN  1  1/2681 (0.04%) 
PUBIC RAMI FRACTURE  1  1/2681 (0.04%) 
ROAD TRAFFIC ACCIDENT  1  1/2681 (0.04%) 
SEROMA  1  1/2681 (0.04%) 
THORACIC VERTEBRAL FRACTURE  1  1/2681 (0.04%) 
TIBIA FRACTURE  1  1/2681 (0.04%) 
TRAUMATIC BRAIN INJURY  1  1/2681 (0.04%) 
VASCULAR GRAFT COMPLICATION  1  1/2681 (0.04%) 
WOUND  1  1/2681 (0.04%) 
WOUND DEHISCENCE  1  1/2681 (0.04%) 
Investigations   
BLOOD CREATININE INCREASED  1  1/2681 (0.04%) 
BLOOD GLUCOSE DECREASED  1  1/2681 (0.04%) 
BLOOD URINE  1  1/2681 (0.04%) 
CATHETERISATION CARDIAC  1  1/2681 (0.04%) 
Metabolism and nutrition disorders   
FLUID OVERLOAD  1  4/2681 (0.15%) 
HYPOKALAEMIA  1  3/2681 (0.11%) 
DIABETIC KETOACIDOSIS  1  2/2681 (0.07%) 
HYPERGLYCAEMIA  1  2/2681 (0.07%) 
HYPERKALAEMIA  1  2/2681 (0.07%) 
DEHYDRATION  1  1/2681 (0.04%) 
DIABETES MELLITUS  1  1/2681 (0.04%) 
DIABETIC FOOT  1  1/2681 (0.04%) 
DYSLIPIDAEMIA  1  1/2681 (0.04%) 
HYPONATRAEMIA  1  1/2681 (0.04%) 
OBESITY  1  1/2681 (0.04%) 
Musculoskeletal and connective tissue disorders   
PAIN IN EXTREMITY  1  3/2681 (0.11%) 
ARTHRALGIA  1  2/2681 (0.07%) 
MUSCULOSKELETAL CHEST PAIN  1  2/2681 (0.07%) 
OSTEOARTHRITIS  1  2/2681 (0.07%) 
ARTHRITIS  1  1/2681 (0.04%) 
BACK PAIN  1  1/2681 (0.04%) 
BONE PAIN  1  1/2681 (0.04%) 
CERVICAL SPINAL STENOSIS  1  1/2681 (0.04%) 
COSTOCHONDRITIS  1  1/2681 (0.04%) 
FLANK PAIN  1  1/2681 (0.04%) 
LUMBAR SPINAL STENOSIS  1  1/2681 (0.04%) 
MUSCULOSKELETAL DISCOMFORT  1  1/2681 (0.04%) 
MUSCULOSKELETAL PAIN  1  1/2681 (0.04%) 
PAIN IN JAW  1  1/2681 (0.04%) 
POLYMYALGIA RHEUMATICA  1  1/2681 (0.04%) 
ROTATOR CUFF SYNDROME  1  1/2681 (0.04%) 
SPINAL COLUMN STENOSIS  1  1/2681 (0.04%) 
SPINAL OSTEOARTHRITIS  1  1/2681 (0.04%) 
SYNOVIAL CYST  1  1/2681 (0.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
ENDOMETRIAL CANCER  1  2/2681 (0.07%) 
LUNG NEOPLASM MALIGNANT  1  2/2681 (0.07%) 
NON-SMALL CELL LUNG CANCER STAGE IV  1  2/2681 (0.07%) 
ADENOCARCINOMA PANCREAS  1  1/2681 (0.04%) 
B-CELL LYMPHOMA  1  1/2681 (0.04%) 
BENIGN NEOPLASM  1  1/2681 (0.04%) 
BLADDER CANCER  1  1/2681 (0.04%) 
BREAST CANCER  1  1/2681 (0.04%) 
BRONCHIAL CARCINOMA  1  1/2681 (0.04%) 
COLON CANCER  1  1/2681 (0.04%) 
GASTRIC CANCER  1  1/2681 (0.04%) 
LIP AND/OR ORAL CAVITY CANCER  1  1/2681 (0.04%) 
LUNG CANCER METASTATIC  1  1/2681 (0.04%) 
LUNG NEOPLASM  1  1/2681 (0.04%) 
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED  1  1/2681 (0.04%) 
LYMPHOMA  1  1/2681 (0.04%) 
MALIGNANT MELANOMA  1  1/2681 (0.04%) 
METASTATIC GASTRIC CANCER  1  1/2681 (0.04%) 
OESOPHAGEAL CARCINOMA  1  1/2681 (0.04%) 
PANCREATIC CARCINOMA  1  1/2681 (0.04%) 
PROSTATE CANCER  1  1/2681 (0.04%) 
PROSTATE CANCER METASTATIC  1  1/2681 (0.04%) 
SARCOMA  1  1/2681 (0.04%) 
SARCOMA METASTATIC  1  1/2681 (0.04%) 
TUMOUR HAEMORRHAGE  1  1/2681 (0.04%) 
Nervous system disorders   
SYNCOPE  1  17/2681 (0.63%) 
CEREBROVASCULAR ACCIDENT  1  13/2681 (0.48%) 
CAROTID ARTERY STENOSIS  1  11/2681 (0.41%) 
TRANSIENT ISCHAEMIC ATTACK  1  7/2681 (0.26%) 
ENCEPHALOPATHY  1  4/2681 (0.15%) 
PRESYNCOPE  1  3/2681 (0.11%) 
CEREBRAL INFARCTION  1  2/2681 (0.07%) 
DYSARTHRIA  1  2/2681 (0.07%) 
HEADACHE  1  2/2681 (0.07%) 
SUBARACHNOID HAEMORRHAGE  1  2/2681 (0.07%) 
BASAL GANGLIA INFARCTION  1  1/2681 (0.04%) 
BRAIN STEM STROKE  1  1/2681 (0.04%) 
CAROTID ARTERY DISEASE  1  1/2681 (0.04%) 
CARPAL TUNNEL SYNDROME  1  1/2681 (0.04%) 
CEREBRAL HAEMORRHAGE  1  1/2681 (0.04%) 
CONVULSION  1  1/2681 (0.04%) 
ENCEPHALITIS  1  1/2681 (0.04%) 
HYPOAESTHESIA  1  1/2681 (0.04%) 
LETHARGY  1  1/2681 (0.04%) 
LOSS OF CONSCIOUSNESS  1  1/2681 (0.04%) 
PARAESTHESIA  1  1/2681 (0.04%) 
RADICULAR PAIN  1  1/2681 (0.04%) 
SCIATICA  1  1/2681 (0.04%) 
Psychiatric disorders   
ANXIETY  1  1/2681 (0.04%) 
BIPOLAR DISORDER  1  1/2681 (0.04%) 
CONVERSION DISORDER  1  1/2681 (0.04%) 
DELIRIUM  1  1/2681 (0.04%) 
DEPRESSION  1  1/2681 (0.04%) 
Renal and urinary disorders   
RENAL FAILURE ACUTE  1  13/2681 (0.48%) 
RENAL FAILURE CHRONIC  1  4/2681 (0.15%) 
NEPHROLITHIASIS  1  3/2681 (0.11%) 
RENAL ARTERY STENOSIS  1  3/2681 (0.11%) 
RENAL FAILURE  1  3/2681 (0.11%) 
URINARY RETENTION  1  3/2681 (0.11%) 
HAEMATURIA  1  2/2681 (0.07%) 
RENAL TUBULAR NECROSIS  1  2/2681 (0.07%) 
BLADDER OBSTRUCTION  1  1/2681 (0.04%) 
CALCULUS URETERIC  1  1/2681 (0.04%) 
RENAL COLIC  1  1/2681 (0.04%) 
RENAL DISORDER  1  1/2681 (0.04%) 
URETHRAL MEATUS STENOSIS  1  1/2681 (0.04%) 
URETHRAL STENOSIS  1  1/2681 (0.04%) 
Reproductive system and breast disorders   
POSTMENOPAUSAL HAEMORRHAGE  1  1/2681 (0.04%) 
PROSTATITIS  1  1/2681 (0.04%) 
Respiratory, thoracic and mediastinal disorders   
DYSPNOEA  1  24/2681 (0.90%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  19/2681 (0.71%) 
ACUTE RESPIRATORY FAILURE  1  13/2681 (0.48%) 
PULMONARY EMBOLISM  1  7/2681 (0.26%) 
RESPIRATORY FAILURE  1  6/2681 (0.22%) 
DYSPNOEA EXERTIONAL  1  4/2681 (0.15%) 
EPISTAXIS  1  3/2681 (0.11%) 
PNEUMONIA ASPIRATION  1  4/2681 (0.15%) 
PULMONARY OEDEMA  1  4/2681 (0.15%) 
ASTHMA  1  3/2681 (0.11%) 
COUGH  1  2/2681 (0.07%) 
HYPOXIA  1  2/2681 (0.07%) 
LUNG INFILTRATION  1  2/2681 (0.07%) 
PLEURAL EFFUSION  1  2/2681 (0.07%) 
PNEUMOTHORAX  1  2/2681 (0.07%) 
RESPIRATORY DISTRESS  1  2/2681 (0.07%) 
ACUTE PULMONARY OEDEMA  1  1/2681 (0.04%) 
ALLERGIC BRONCHITIS  1  1/2681 (0.04%) 
CHRONIC RESPIRATORY FAILURE  1  1/2681 (0.04%) 
HAEMOPTYSIS  1  1/2681 (0.04%) 
MEDIASTINAL MASS  1  1/2681 (0.04%) 
PNEUMONITIS  1  1/2681 (0.04%) 
PULMONARY FIBROSIS  1  1/2681 (0.04%) 
PULMONARY HYPERTENSION  1  1/2681 (0.04%) 
ABDOMINAL PAIN UPPER  1  2/2681 (0.07%) 
Skin and subcutaneous tissue disorders   
ANGIOEDEMA  1  1/2681 (0.04%) 
Surgical and medical procedures   
CAROTID ENDARTERECTOMY  1  1/2681 (0.04%) 
Vascular disorders   
INTERMITTENT CLAUDICATION  1  9/2681 (0.34%) 
DEEP VEIN THROMBOSIS  1  8/2681 (0.30%) 
HYPERTENSION  1  7/2681 (0.26%) 
HYPOTENSION  1  7/2681 (0.26%) 
AORTIC STENOSIS  1  4/2681 (0.15%) 
ARTERIOSCLEROSIS  1  3/2681 (0.11%) 
FEMORAL ARTERY OCCLUSION  1  3/2681 (0.11%) 
HAEMATOMA  1  3/2681 (0.11%) 
PERIPHERAL ISCHAEMIA  1  3/2681 (0.11%) 
PERIPHERAL VASCULAR DISORDER  1  3/2681 (0.11%) 
HYPERTENSIVE CRISIS  1  2/2681 (0.07%) 
MALIGNANT HYPERTENSION  1  2/2681 (0.07%) 
ACCELERATED HYPERTENSION  1  1/2681 (0.04%) 
AORTIC ANEURYSM  1  1/2681 (0.04%) 
ARTERIAL THROMBOSIS  1  1/2681 (0.04%) 
ARTERIAL THROMBOSIS LIMB  1  1/2681 (0.04%) 
FEMORAL ARTERY ANEURYSM  1  1/2681 (0.04%) 
HOT FLUSH  1  1/2681 (0.04%) 
ISCHAEMIA  1  1/2681 (0.04%) 
ISCHAEMIC LIMB PAIN  1  1/2681 (0.04%) 
LYMPHOEDEMA  1  1/2681 (0.04%) 
ORTHOSTATIC HYPOTENSION  1  1/2681 (0.04%) 
PERIPHERAL COLDNESS  1  1/2681 (0.04%) 
SHOCK  1  1/2681 (0.04%) 
TAKAYASU'S ARTERITIS  1  1/2681 (0.04%) 
THROMBOPHLEBITIS  1  1/2681 (0.04%) 
VENOUS THROMBOSIS LIMB  1  1/2681 (0.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.1%
PROMUS Element
Affected / at Risk (%)
Total   5/2681 (0.19%) 
Cardiac disorders   
Myocardial Infarction  1  5/2681 (0.19%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
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
Layout table for Results Point of Contact information
Name/Title: Peter Maurer, Director Clinical Trials
Organization: Boston Scientific
Phone: 508-683-6678
EMail: Peter.Maurer@bsci.com
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01589978     History of Changes
Other Study ID Numbers: S2066
First Submitted: May 1, 2012
First Posted: May 2, 2012
Results First Submitted: January 25, 2016
Results First Posted: May 3, 2016
Last Update Posted: July 25, 2018