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

Coronary Artery Disease Clinical Trial

Official title:

A U.S. Post-Approval Study of the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System Evaluating the SYNERGY XLV (MEGATRON) Stent System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04807439
• Other study ID #: 92226704
• Status: Completed
• Start date: April 14, 2021
• Est. completion date: August 18, 2023

Study information

• Verified date: October 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 18, 2023
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Planned treatment with a non-SYNERGY stent

Related Conditions & MeSH terms

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

Intervention

Device:
• SYNERGY XLV (Megatron) Coronary Stent System
The SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at high risk for bleeding, with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries >3.50 mm to <5.00 mm in diameter in lesions <28 mm in length.

Locations

Country	Name	City	State
United States	Beth Israel Deaconness Medical Center	Boston	Massachusetts
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Baylor Heart and Vascular Hospital	Dallas	Texas
United States	Inova Fairfax Hospital	Fairfax	Virginia
United States	North Kansas City Hospital	Kansas City	Missouri
United States	Yale University	New Haven	Connecticut
United States	Oregon Health Sciences University	Portland	Oregon
United States	Wake Medical Center	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Clinical endpoints	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)	At Hospital Discharge (typically 1-2 days post index procedure), and at 6 months, 12 months, 2 years
Secondary	Periprocedural endpoints	Technical success rate, Clinical procedural success rate	At Hospital Discharge (typically 1-2 days post index procedure)