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
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