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

Sponsor

Boston Scientific Corporation (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03875651

Collaborator

(none)

100

Enrollment

Locations

54.8

Anticipated Duration (Months)

11.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Heart Diseases, Coronary Coronary Artery Disease Cardiovascular Diseases	Device: SYNERGY 4.50 mm and 5.0 mm Coronary Stent System

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

May 9, 2019

Actual Primary Completion Date :

Jan 7, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Wake Medical Center	Raleigh	North Carolina	United States	27607
6	Lindner Center for Research and Education at Christ Hospital	Cincinnati	Ohio	United States	45219
7	Oregon Health Science University	Portland	Oregon	United States	97239
8	Baylor Heart and Vascular Hospital	Dallas	Texas	United States	75226
9	Inova Fairfax Hospital	Fairfax	Virginia	United States	22042