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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P150003 S039/ PAS001 |
| Date Original Protocol Accepted |
03/29/2019
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| Date Current Protocol Accepted |
|
| Study Name |
EVOLVE 4.5/5.0 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
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of the EVOLVE 4.5/5.0 Study is to confirm the safety and effectiveness of SYNERGY 4.50 mm and 5.00 mm Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the treatment of patients with atherosclerotic lesions(s) less than or equal to 28 mm in length (by visual estimate) in native coronary arteries > 4.00 mm to less than or equal to 5.00 mm in diameter (by visual estimate).
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| Study Population |
US patients who are acceptable candidates for treatment with a 4.50 or 5.00 mm SYNERGY stent if treated in accordance with the applicable guidelines on PCI, the SYNERGY DFU, and the Declaration of Helsinki. Sites should approach consecutive patients for inclusion in the trial
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| Sample Size |
A minimum of 100 subjects will be enrolled at up to 20 US sites.
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| Key Study Endpoints |
The primary endpoint is the rate of Target Lesion Failure (TLF) rate at 12-months. Secondary endpoints include rates of TLR, TLF, TVR, TVF, MI (Q-Wave and non-Q-wave), Death (All, Cardiac, Non-Cardiac), Cardiac Death or MI, All Death or MI, All Death or MI or TVR, Stent Thrombosis (ARC Definitions) at 6-months, 12-months, 2-years, and 3-years. In addition, secondary endpoints will technical and clinical success rates.
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| Follow-up Visits and Length of Follow-up |
3 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
100
|
| Actual Number of Sites Enrolled |
9
|
| Patient Follow-up Rate |
All subjects have completed follow-up.
|
| Final Safety Findings |
This study has completed enrollment (n=100) and 3-years (36 months) of follow-up. Principal safety and efficacy outcomes are presented in Table 6.8-5. Within the 1 3-year timeframe:
There were 4 additional cardiac deaths.
A total of 4 patients experienced MI that was target vessel related.
The incidence of TLR occurred in 2 patients.
|
| Final Effect Findings |
Principal safety and efficacy outcomes through 3 years of follow-up in the ITT population are shown in Table 6.8-5.
The incidence of TLR occurred in 3 patients.
There was a total of 10 deaths, with 7 being cardiac-related.
Nine subjects experienced target-vessel related MI.
None of the subjects experienced a definite or probable ST.
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| Study Strengths & Weaknesses |
The study has a limited sample size with a fairly heterogenous patient population, however, the results continue to support the performance of the study device in the US patient population.
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| Recommendations for Labeling Changes |
A labeling revision is recommended
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