Revascularization With BVS or CABG in Patients With Advanced CAD

• Register: ClinicalTrials.gov
• Last refreshed on: 5 December 2016
• Main ID: NCT02334826
• Date of registration: 06/01/2015
• Prospective Registration: Yes
• Primary sponsor: Poznan University of Medical Sciences
• Public title: Revascularization With BVS or CABG in Patients With Advanced CAD RELEASE-BVS
• Scientific title: Revascularization With the Use of Biodegradable Scaffolds Compared to CABG in Patients With Advanced Stable Ischemic Heart Disease
• Date of first enrolment: February 2015
• Target sample size: 11
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02334826
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Poland

Contacts

• Name: Maciej Lesiak, MD, PhD
• Affiliation: Department of Cardiology, Poznan University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multivessel Coronary Artery Disease

Intervention(s)

Procedure: PCI -BVS

Procedure: CABG

Primary Outcome(s)

Extent of ischemia and left ventricular ejection fraction in cardiovascular magnetic resonance [Time Frame: 12 months after procedure]

Secondary Outcome(s)

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 [Time Frame: at 30-day after procedure and annually up to 5 years]

Patency of coronary arteries and grafts in computed tomography angiography [Time Frame: 12 months after procedure]

Secondary ID(s)

Poznan01/2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors