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NCT03875651 Clinical Trial

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

Coronary Artery Disease Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03875651
Other study ID # S2357
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 9, 2019
Est. completion date November 28, 2023

Study information
Verified date December 2023
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 28, 2023
Est. primary completion date January 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• SYNERGY 4.50 mm and 5.0 mm Coronary Stent System
The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System), manufactured by BSC, is a device/drug combination product comprised of two regulated components: a device (Coronary Stent System) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).

Locations
Country Name City State
United States Beth Israel Deaconness Medical Center Boston Massachusetts
United States Lindner Center for Research and Education at Christ Hospital Cincinnati Ohio
United States Clearwater Cardiovascular Consultants Clearwater Florida
United States Baylor Heart and Vascular Hospital Dallas Texas
United States Inova Fairfax Hospital Fairfax Virginia
United States North Kansas City Hospital Kansas City Missouri
United States Yale New Haven Hospital New Haven Connecticut
United States Oregon Health Science University Portland Oregon
United States Wake Medical Center Raleigh North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Target Lesion Failure (TLF) rate 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. 12-months
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