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Feasibility and Outcomes of Complete Coronary Revascularization Using BVS in All-comer Patients With Angina

NCT02707783 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1602

Last updated 2018-12-13

No results posted yet for this study

Summary

The aim of the study is feasibility of complete coronary revascularization with bioresorbable vascular scaffold (BVS) implantation and assessment of treatment outcomes in a group of consecutive patients with stable and unstable angina in Russian population.

The hypothesis of this registry study: 1) Complete coronary revascularization with BVS implantation will be feasible to perform in at least 70 percent of patient population with stable and unstable angina qualified for revascularization after coronary angiography, 2) Complete revascularization with BVS is as safe and effective as revascularization with standard BMS (Bare Metal Stent BMS/ Drug Eluting Stent DES stent implantation (published literature comparators in matched populations).

Up to 2500 patients will be enrolled in 13 Russian high volume invasive cardiology centres. 12 month clinical observation and 5-year clinical follow-up is expected.

Conditions

  • Angina

Interventions

DEVICE

Bioresorbable vascular scaffold (BVS) implantation

Sponsors & Collaborators

  • KCRI

    collaborator OTHER

  • International Foundation for Development of Medical Science and Education Healthy Heart

    lead OTHER

Principal Investigators

  • Piotr Musiałek, MD DPhil · John Paul II Hospital in Krakow, Poland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-06-30
Completion
2018-07-31

Countries

  • Russia

Study Locations

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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 NCT02707783 on ClinicalTrials.gov