|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P150003 S055/ PAS001 |
Date Original Protocol Accepted |
05/28/2020
|
Date Current Protocol Accepted |
 
|
Study Name |
SYNERGY PAS
|
Device Name |
SYNERGY™ XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™)
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
Objective Performance Criterion
|
Analysis Type |
Descriptive
|
Study Population |
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
To assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) > 34 mm and less than or equal to 44 mm in length (by visual estimate) in native coronary arteries greater than or equal to 2.5 mm to less than or equal to 4.0 mm in diameter (by visual estimate).
|
Study Population |
patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries from 2.50 - 4.00mm (nominal) in diameter, and > 34 mm and less than or equal to 44 mm lesion lengths
|
Sample Size |
100
|
Key Study Endpoints |
The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel, or cardiac death.
|
Follow-up Visits and Length of Follow-up |
1 year follow-up
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
100
|
Actual Number of Sites Enrolled |
10
|
Patient Follow-up Rate |
1 year
|
Final Safety Findings |
Two patients had a MI that was related to the target vessel None of the patients experienced a definite or probable ST through 12 months
|
Final Effect Findings |
The trial primary endpoint was met: the rate of 12-month TLF was 4.1% in both the ITT and per-protocol population (one-sided 95% upper confidence bound of 9.1%), which was significantly less than the performance goal of 19.5% (P<0.0001) There was a total of 5 deaths at 12-months and 1 of these was cardiac-related The rates of technical and clinical procedural success were 100.0%
|
Study Strengths & Weaknesses |
Single arm trial with a limited sample size for confirmatory analysis.
|
Recommendations for Labeling Changes |
none
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