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)
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Contact
Alan C Yeung, MD
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