|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P150003 / PAS001 |
| Date Original Protocol Accepted |
10/02/2015
|
| Date Current Protocol Accepted |
05/12/2017
|
| Study Name |
EVOLVE Short DAPT Study
|
| Device Name |
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The EVOLVE Short DAPT clinical trial is a prospective, multicenter, single-arm study designed to assess the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System).
|
| Study Population |
Device: SYNGERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
Subject considered at high risk for bleeding, defined as meeting one or more of the following criteria at the time of enrollment: =75 years of age, current anticoagulation therapy, history of major bleeding, stroke, or renal insufficiency (creatinine =2.0 mg/dl) or renal failure (dialysis dependent).
Control:
Historical data collected from subjects at high risk for bleeding receiving 12 months of DAPT
|
| Sample Size |
2,250 subjects will be enrolled in up to 120 sites worldwide in the United States, Europe, Japan, and Brazil.
Number of evaluable test subjects required in the propensity score model is 1,650 (1,500 *1.1) including additional 10% subjects accounting for model variability
Expected drop out rate due to ineligibility for 3 month DAPT in 0 to 3 months = 15%
Expected attrition rate in 3 to 15 months = 3%
|
| Key Study Endpoints |
Co-Primary Endpoints: The study has two co-primary endpoints which will be assessed: (1) rate of death and myocardial infarction between 3- and 15- months and (2) rate of Academic Research Consortium (ARC) definite/probable stent thrombosis (ST) involving SYNERGY between 3 and 15 months.
Secondary Endpoint: Rate of bleeding, based upon the Bleeding Academic Research Consortium (BARC) classification (types 2, 3, and 5) between 3 and 15 months in subjects not taking chronic anticoagulation.
|
| Follow-up Visits and Length of Follow-up |
All enrolled subjects are to be followed through 15 months after the index procedure. The study will be considered complete with regard to the primary endpoint after all subjects have completed 15-months follow-up.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
2009
|
| Actual Number of Sites Enrolled |
110
|
| Patient Follow-up Rate |
1767/2009 (88.0%) available for 15-month follow-up
|
| Final Safety Findings |
Co-Primary Endpoint (1) death or MI: 5.58%
Co-Primary Endpoint (2) Academic Research Consortium (ARC) definite/probable Stent Thrombosis: 0.2%
|
| Study Strengths & Weaknesses |
prospective, multicenter, single-arm study designed to assess and underserved patient population (high risk for bleeding)
|
| Recommendations for Labeling Changes |
Revisions to the labeling will be recommend that provide additional information and context regarding the clinical study that was performed.
|
