A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)

About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

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 CRITERIA

Exclusion Criteria:

Planned treatment with a non-SYNERGY stent.

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details

Contition

Atherosclerosis,Heart Diseases, Coronary,Coronary Artery Disease,Cardiovascular Diseases

Age (in years)

18+

Participants needed

100

Est. Completion Date

Dec 31, 2023

Treatment type

Observational

Sponsor

Boston Scientific Corporation

ClinicalTrials.gov identifier

NCT03875651

Study number

S2357

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