NCT03875651Completed
A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)
A U.S. Post-Approval Study of the SYNERGY 4.50/5.00 mm Everolimus-Eluting Platinum Chromium Coronary Stent System (Evolve 4.5/5.0)
Source: ClinicalTrials.gov · Last updated 14 Dec 2023
Brief summary (registry, in English)
EVOLVE 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the SYNERGY 4.50 mm and 5.00 mm Coronary Stent System for the treatment of patients with coronary artery disease in large vessels (≤ 28 mm in length, by visual estimate, in native coronary arteries \> 4.00 mm to ≤5.00 mm in diameter, by visual estimate). This Post Approval study is a cohort associated with the SYNERGY MEGATRON Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT04807439.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 13 Mar 2019
- Start date
- 9 May 2019
- Primary completion date
- 7 Jan 2022
- Lead sponsor
- Boston Scientific Corporation
- Diseases
- Coronary artery disease
- NCT number
- NCT03875651
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 9 May 2019 to the primary completion date, 7 Jan 2022
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned treatment with a non-SYNERGY stent.
Who the study is looking for
- A patient is an acceptable candidate if they require treatment with a 4.50 or 5.00 mm SYNERGY stent for the treatment of their disease in accordance with the applicable guidelines on PCI, the SYNERGY DFU, and the Declaration of Helsinki.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beth Israel Deaconness Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Lindner Center for Research and Education at Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Clearwater Cardiovascular Consultants Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Baylor Heart and Vascular Hospital Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Inova Fairfax Hospital Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| North Kansas City Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Wake Medical Center Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.