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

NCT03875651 | Completed FDA Device

• 1 other identifier: S2357
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Keywords

Drug-Eluting Stents

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

SYNERGY 4.50 mm and 5.0 mm Coronary Stent System DEVICE

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible patients include those with atherosclerotic coronary lesions with vessel diameters that can appropriately be treated with 4.50 mm and/or 5.00 mm stents according to the commercially approved SYNERGY DFU

You may qualify if:

• 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.

You may not qualify if:

• Planned treatment with a non-SYNERGY stent.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (9)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

Location

Beth Israel Deaconness Medical Center

Boston, Massachusetts, 02215, United States

Location

North Kansas City Hospital

Kansas City, Missouri, 64116, United States

Location

Wake Medical Center

Raleigh, North Carolina, 27607, United States

Location

Lindner Center for Research and Education at Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Oregon Health Science University

Portland, Oregon, 97239, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Inova Fairfax Hospital

Fairfax, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Coronary Disease; Coronary Artery Disease; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Ischemia; Heart Diseases

Study Officials

• Robert C Stoler, MD

  Baylor Heart and Vascular Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 15, 2019
• Study Start: May 9, 2019
• Primary Completion: January 7, 2022
• Study Completion: November 28, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

US (9)