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Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque
Not Recruiting
Trial ID: NCT02316886
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
Stanford Investigator(s)
Alan Yeung, MD
Li Ka Shing Professor in Cardiology
Eligibility
Inclusion 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
Exclusion Criteria:
- 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
Intervention(s):
drug: Optimal Medical treatment
drug: Optimal Medical treatment
device: Coronary intervention
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Alan C Yeung, MD