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

Completed

• Conditions: Heart Diseases, Coronary; Cardiovascular Diseases; Atherosclerosis; Coronary Artery Disease
• Interventions: Device: SYNERGY XLV (Megatron) Coronary Stent System

• Registration Number: NCT04807439
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-19
• Study Start: 2021-04-14
• Primary Completion: 2022-08-19
• Study Completion: 2023-08-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Planned treatment with a non-SYNERGY stent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SYNERGY XLV (Megatron) Coronary Stent System	SYNERGY XLV (Megatron) 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).

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Clinical endpoints	At Hospital Discharge (typically 1-2 days post index procedure), and at 6 months, 12 months, 2 years	TLR rate, TLF rate (primary endpoint at 12 months), Target vessel revascularization (TVR) rate, Target vessel failure (TVF) rate, MI (Q-wave and non-Q-wave) rate, Cardiac death rate, Non-cardiac death rate, All death rate, Cardiac death or MI rate, All death or MI rate, All death/MI/TVR rate, Stent thrombosis rates (ARC)
Periprocedural endpoints	At Hospital Discharge (typically 1-2 days post index procedure)	Technical success rate, Clinical procedural success rate

Trial Locations

Locations (8)

Clearwater Cardiovascular Consultants; 🇺🇸 Clearwater, Florida, United States

Inova Fairfax Hospital; 🇺🇸 Fairfax, Virginia, United States

Wake Medical Center; 🇺🇸 Raleigh, North Carolina, United States

Baylor Heart and Vascular Hospital; 🇺🇸 Dallas, Texas, United States

Beth Israel Deaconness Medical Center; 🇺🇸 Boston, Massachusetts, United States

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States

North Kansas City Hospital; 🇺🇸 Kansas City, Missouri, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States