Trials / Completed
CompletedNCT03350542
A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)
EVOLVE 48: A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGY 48 mm Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
EVOLVE 48 is a prospective, open label, single arm, multi-center trial. The purpose of this study is 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 ≤ 44 mm in length (by visual estimate) in native coronary arteries ≥2.5 mm to ≤4.0 mm in diameter (by visual estimate).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SYNERGY 48 mm | A drug eluting coronary stent system |
Timeline
- Start date
- 2018-04-12
- Primary completion
- 2020-01-16
- Completion
- 2021-01-08
- First posted
- 2017-11-22
- Last updated
- 2021-05-14
- Results posted
- 2021-02-05
Locations
15 sites across 4 countries: United States, Latvia, New Zealand, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03350542. Inclusion in this directory is not an endorsement.