Education and Training
Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Optimal Medical treatment
- drug: Optimal Medical treatment
- device: Coronary intervention
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Alan C Yeung, MD
Not Recruiting