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

• Registration Number: NCT03875651
• Lead Sponsor: Boston Scientific Corporation

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Study Start: 2019-05-09
• Primary Completion: 2022-01-07
• Study Completion: 2023-11-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Planned treatment with a non-SYNERGY stent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF) rate	12-months	12-month Target Lesion Failure (TLF) rate, defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.

Trial Locations

Locations (9)

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