A U.S Post Approval Study Evaluating the SYNERGY XLV (MEGATRON) Stent System

Boston Scientific

Status: Completed

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

Treatments: Device: SYNERGY XLV (Megatron) Coronary Stent System

Study type: Observational

Funder types: Industry

Identifiers

NCT04807439

92226704

Details and patient eligibility

About

This is a post-market, standard of care, real-world observational study to assess the clinical outcomes of the SYNERGY XLV (MEGATRON) Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 28 mm in length (by visual estimate) in native coronary arteries ≥3.50 mm to ≤5.00 mm in diameter (by visual estimate). This Post Approval study is a cohort associated with the Evolve 4.5/5.0 (SYNERGY LV) Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT03875651.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient requires treatment with a SYNERGY XLV (Megatron) stent

Exclusion criteria

• Planned treatment with a non-SYNERGY stent

Trial design

100 participants in 1 patient group

SYNERGY XLV (Megatron) Coronary Stent System

Description:

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).

Treatment:

Device: SYNERGY XLV (Megatron) Coronary Stent System