Revascularization With BVS or CABG in Patients With Advanced CAD

NCT02334826 | Terminated Phase 4 DMC

• 1 other identifier: Poznan01/2015
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

multivessel coronary artery disease; revascularization; bioresorbable vascular scaffold; percutaneous coronary intervention; coronary artery bypass grafting

Outcome Measures

Primary Outcomes (1)

• Extent of ischemia and left ventricular ejection fraction in cardiovascular magnetic resonance

  12 months after procedure

Secondary Outcomes (2)

• Patency of coronary arteries and grafts in computed tomography angiography

  12 months after procedure

• Rates of composite major adverse cardiac and cerebrovascular events (MACCE), such as all-cause death, cardiac death, myocardial infarction, stroke, stent thrombosis, a repeat revascularization

  at 30-day after procedure and annually up to 5 years

Study Arms (2)

PCI - BVS

ACTIVE COMPARATOR

percutaneous coronary intervention with the use of bioresorbable scaffolds (Absorb)

Procedure: PCI -BVS

CABG

ACTIVE COMPARATOR

coronary artery bypass grafting

Procedure: CABG

Interventions

PCI -BVS PROCEDURE

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.

PCI - BVS

CABG PROCEDURE

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.

CABG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age ≥18 years
• Patient with symptomatic stable CAD or silent ischemia, with 3-vessel disease and/or significant stenosis of left main coronary artery on angiography, with significant ischemia evaluated in stress CMR
• Patient suitable for both PCI or CABG after local heart team evaluation
• Patient understands and accepts the meaning and the aims of the study and is willing to sign written informed consent

You may not qualify if:

• Prior CABG
• Concomitant valve disease requiring cardiac surgery
• Metal implants that may be the contraindication for CMR examination (e.g. peacemaker, ICD)
• Other contraindication for stress CMR or computed tomography (claustrophobia, asthma, a-v bloc, allergy to radiographic contrast or any prior anaphylaxis to contrast)
• Contraindication for 12 months dual antiplatelet therapy (DAPT) or known allergy to acetylsalicylic acid, clopidogrel or ticagrelor
• Female patient with child bearing potential
• Acute coronary syndrome within 2 weeks prior to revascularization
• Significant stenosis of any vessel, including LM if reference diameter \> 4mm
• left ventricular ejection fraction (LVEF) \<35%
• Life expectancy \< 12 months
• Stroke or transient ischemic attack (TIA) within 3 months prior to revascularization
• Chronic kidney disease, estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73m2
• Planned surgery (other than CABG) within 12 months after randomization
• Diathesis, chronic oral anticoagulation therapy or history of bleeding
• Current participation in another trial or registry

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Department of Cardiology, Poznan University of Medical Sciences

Poznan, 61-848, Poland

Location

Study Officials

• Maciej Lesiak, MD, PhD

  Department of Cardiology, Poznan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 8, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: August 1, 2022
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

PL (1)