Trials / Completed
CompletedNCT04807439
A U.S Post Approval Study Evaluating the SYNERGY XLV (MEGATRON) Stent System
A U.S. Post-Approval Study of the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System Evaluating the SYNERGY XLV (MEGATRON) Stent System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a post-market, standard of care, real-world observational study to assess the clinical outcomes of the SYNERGY XLV (MEGATRON) Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 28 mm in length (by visual estimate) in native coronary arteries ≥3.50 mm to ≤5.00 mm in diameter (by visual estimate). This Post Approval study is a cohort associated with the Evolve 4.5/5.0 (SYNERGY LV) Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT03875651.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SYNERGY XLV (Megatron) Coronary Stent System | The SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at high risk for bleeding, 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 \>3.50 mm to \<5.00 mm in diameter in lesions \<28 mm in length. |
Timeline
- Start date
- 2021-04-14
- Primary completion
- 2022-08-19
- Completion
- 2023-08-18
- First posted
- 2021-03-19
- Last updated
- 2023-10-23
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04807439. Inclusion in this directory is not an endorsement.