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NCT01665053 · ClinicalTrials.gov registry record · Phase 3
The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
A Phase 3 study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,684
- Enrollment target
NCT01665053: Completed Phase 3 study, sponsored by Boston Scientific Corporation.
NCT01665053 is a Phase 3 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 1,684 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (118% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01665053, a Phase 3 study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,684 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).
Primary Outcome
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
Interventions
- DEVICE PROMUS Element Plus
- DEVICE SYNERGY
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,684 participants |
| Start Date | 2012-11 |
| Est. Completion | 2018-12-22 |
| Phase | Phase 3 |
What the finished NCT01665053 record still lists
NCT01665053 is an interventional study that assigns participants to a tested intervention. Its 1,684 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (118% higher).
The record links to 0 conditions, and to 2 interventions - of which PROMUS Element Plus is the first listed.
NCT01665053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01665053 about?
NCT01665053 is a clinical study titled "The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)". The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diamete...
What is the current status of trial NCT01665053?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,684 participants. The study started on 2012-11. Estimated completion is 2018-12-22.
What interventions are being tested in trial NCT01665053?
The interventions under investigation include: PROMUS Element Plus (DEVICE), SYNERGY (DEVICE).
Who is sponsoring clinical trial NCT01665053?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01665053's enrollment target sits among peer trials
1,684 134th of 2000 higher than 1,867 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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