Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
The primary aim of the trial is to determine whether preventive PCI with bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) plus optimal medical therapy (OMT) on functionally insignificant (FFR > 0.80) vulnerable coronary plaque, as determined by intracoronary imaging, would result in a significant reduction of the primary composite outcome of death from cardiac causes, target-vessel myocardial infarction (MI), target-vessel revascularization (TVR), and hospitalization for unstable or progressive angina at 2 years, when compared with OMT alone.
Official Title
a Multinational, Multicenter, Prospective, Open-label, Active-treatment-controlled Randomized Trial: Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque_PREVENT Trial
Eligibility Criteria
- - Patients aged ≥18 years - Patients with suspected or known Coronary artery disease who are undergoing invasive cardiac catheterization - Patients with at least one significant stenosis (diameter stenosis >50%) with Fractional Flow Reserve (FFR) >0.80 and meeting two of the following criteria: 1. MLA(minimal luminal area)<4mm2 2. Plaque burden>70% 3. Large lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy), defined as MaxLCBI4mm>315 4. TCFA(thin-cap fibroatheroma) defined as fibrous cap thickness <65 μm and arc >90° on optical coherence tomography (OCT) or ≥10% confluent necrotic core with >30° abutting the lumen in three consecutive slices on Virtual-histology intravascular ultrasound (VH-IVUS) - Eligible for percutaneous coronary intervention with Absorb Bioresorbable Vascular Scaffold or Everolimus Eluting Stent - Reference vessel diameter 2.75-4.0 - Lesion length ≤ 40mm - Willing and able to provide informed written consent
- - Patients for whom the preferred treatment is CABG(Coronary artery bypass grafting) - Patients with stented lesions - Patients with bypass graft lesions - Patients with three or more target lesions - Patients with two target lesions in the same coronary territory - Patients with heavily calcified or angulated lesions - Patients with bifurcation lesions requiring 2 stenting technique - Patients with contraindications to or planned discontinuation of dual antiplatelet therapy within 1 year - Patients with life expectancy <2 years - Patients with planned cardiac or major noncardiac surgery - Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Alan C Yeung, MD
View on ClinicalTrials.gov
