Status:
COMPLETED
A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Atherosclerosis
Heart Diseases, Coronary
Eligibility:
All Genders
18+ years
Brief Summary
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 Syst...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Planned treatment with a non-SYNERGY stent.
Key Trial Info
Start Date :
May 9 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 28 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03875651
Start Date
May 9 2019
End Date
November 28 2023
Last Update
December 14 2023
Active Locations (9)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
2
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States, 33756
3
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States, 02215
4
North Kansas City Hospital
Kansas City, Missouri, United States, 64116