KCT0002893Recruiting未知
The Preventive Coronary Intervention on Stenosis With Functionally Insignificant Vulnerable Plaque
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Asan Medical Center
- Enrollment
- 1,600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 19(Year) to o Limit (—)
- Sex
- All
Inclusion Criteria
- •Age 19 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:
- •MLA(minimal luminal area)<4mm2
- •plaque burden>70%
- •Lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy) (defined as maxLCBI4mm>315)
- •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
Investigators
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