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

NCT ID: NCT03875651

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-09

Study Completion Date

2023-11-28

Brief Summary

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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

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Conditions

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Atherosclerosis Heart Diseases, Coronary Coronary Artery Disease Cardiovascular Diseases

Keywords

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Drug-Eluting Stents

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert C Stoler, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Heart and Vascular Hospital

Locations

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Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Clearwater Cardiovascular Consultants

Clearwater, Florida, United States

Site Status

Beth Israel Deaconness Medical Center

Boston, Massachusetts, United States

Site Status

North Kansas City Hospital

Kansas City, Missouri, United States

Site Status

Wake Medical Center

Raleigh, North Carolina, United States

Site Status

Lindner Center for Research and Education at Christ Hospital

Cincinnati, Ohio, United States

Site Status

Oregon Health Science University

Portland, Oregon, United States

Site Status

Baylor Heart and Vascular Hospital

Dallas, Texas, United States

Site Status

Inova Fairfax Hospital

Fairfax, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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S2357

Identifier Type: -

Identifier Source: org_study_id