Trial Search Results

The Preventive Coronary Intervention on Stenosis With Functionally Insignificant Vulnerable Plaque

The purpose of this study is to determine whether preventive coronary intervention on functionally insignificant coronary stenosis with vulnerable plaque characteristics plus optimal medical therapy reduces the incidence of the composite of cardiovascular death, target vessel myocardial infarction, or ischemia driven target lesion revascularization compared with optimal medical therapy alone.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Seung-Jung Park

Collaborator: CardioVascular Research Foundation, Korea

Stanford Investigator(s):

Intervention(s):

  • Device: Coronary intervention
  • Drug: Optimal Medical treatment

Phase:

Phase 4

Eligibility


Inclusion Criteria:

   - Age 18 years or older

   - Symptomatic or asymptomatic coronary artery disease patients

   - Patients having at least one significant stenosis (diameter stenosis > 50%) with FFR
   >0.80 and meeting two of the following:

      1. MLA(minimal luminal area)<4mm2

      2. plaque burden>70%

      3. Lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy) (defined as
      maxLCBI4mm>315)

      4. TCFA(thin-cap fibroatheroma) defined by OCT(fibrous cap thickness<65µm and
      arc>90°) or VH-IVUS≥10% confluent NC with>30° abutting to the lumen in 3
      consecutive slices)

         - 2 target vulnerable lesions

   - Eligible for percutaneous coronary intervention with Absorb Bioresorbable Vascular
   Scaffold or Everolimus Eluting Stent

   - Willing and able to provide informed written consent

   - Reference vessel diameter 2.75-4.0

   - Lesion length ≤ 40

Exclusion Criteria:

   - Patients in whom the preferred treatment is CABG(Coronary artery bypass grafting)

   - Stented lesion

   - Bypass graft lesion

   - The patients who have more than or equal to 3 target lesions

   - 2 target lesions in the same coronary territory

   - Heavily calcified or angulated lesion

   - Bifurcation lesion requiring 2 stenting technique

   - Contraindication to or planned discontinuation of dual antiplatelet therapy within 1
   year

   - Life expectancy less than 2 years

   - Planned cardiac surgery or planned major non cardiac 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