The Preventive Coronary Intervention on Stenosis With Functionally Insignificant Vulnerable Plaque

• Status: Active, not recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seung-Jung Park
• Collaborator: CardioVascular Research Foundation, Korea

Criteria

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