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

NCT04807439 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-10-23

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Robert C Stoler, MD · Baylor Heart and Vascular Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2022-08-19
Completion
2023-08-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04807439 on ClinicalTrials.gov