A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)
Completed
Conditions studied: Atherosclerosis, Heart Diseases, Coronary, Coronary Artery Disease, Cardiovascular Diseases
In brief
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.
Key facts
- Study ID
- NCT03875651
- Run by
- Boston Scientific Corporation
- People needed
- 100
- Starts
- 2019-05-09
- Expected to finish
- 2023-11-28
- Last updated by the study team
- 2023-12-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Planned treatment with a non-SYNERGY stent.
Where it is running
- Yale New Haven Hospital — New Haven, Connecticut, United States
- Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
- Beth Israel Deaconness Medical Center — Boston, Massachusetts, United States
- North Kansas City Hospital — Kansas City, Missouri, United States
- Wake Medical Center — Raleigh, North Carolina, United States
- Lindner Center for Research and Education at Christ Hospital — Cincinnati, Ohio, United States
- Oregon Health Science University — Portland, Oregon, United States
- Baylor Heart and Vascular Hospital — Dallas, Texas, United States
- Inova Fairfax Hospital — Fairfax, Virginia, United States
Full record on ClinicalTrials.gov
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