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Revascularization With BVS or CABG in Patients With Advanced CAD

NCT02334826 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2016-11-28

No results posted yet for this study

Summary

The purpose of the study is to investigate the extent of ischemia and left ventricular function in cardiovascular magnetic resonance (CMR), as well as patency of coronary arteries and grafts in coronary computed tomography angiography at 12 months follow up in patients with advanced coronary artery disease treated with percutaneous coronary intervention with the implantation of bioresorbable scaffolds or coronary artery bypass graft surgery.

Additionally, the clinical results of the two methods of revascularization will be carried out annually up to 5 years.

Conditions

  • Multivessel Coronary Artery Disease

Interventions

PROCEDURE

PCI -BVS

All patients in the PCI arm will be treated with bioresorbable scaffolds (Absorb). Lesions in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate) will be treated after confirmation of functional significance with iFR/FFR.

PROCEDURE

CABG

In the CABG arm the surgery will be carried out according to the routine practice, with the intention of complete revascularization and frequent use of arterial grafts.

Sponsors & Collaborators

  • Poznan University of Medical Sciences

    lead OTHER

Principal Investigators

  • Maciej Lesiak, MD, PhD · Department of Cardiology, Poznan University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-09-30
Completion
2022-08-31

Countries

  • Poland

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 NCT02334826 on ClinicalTrials.gov