Coronary Artery Disease
Conditions
Keywords
OCT, IVUS, BVS
Brief summary
The primary objective is to determine whether IVUS- (vs. OCT-) guided BVS implantation is non-inferior to achieve a large in-scaffold minimal lumen area (primary endpoint) measured by OCT at 1-year follow-up.
Interventions
comparative method for BVS
The method of goldstandard for decision stent choice
Sponsors
Abbott Medical Devices
Young-Hak Kim, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 20 years or older * Patients who have at least one epicardial coronary artery lesion with an evidence of inducible ischemia * Willing and able to provide informed written consent * Eligible for PCI
Exclusion criteria
* Patients presenting with STEMI within 2 weeks * Bypass graft lesion * Lesion with left main disease * Expected length of scaffold \> 40 mm * Bifurcation lesion requiring side branch stenting * Small vessels \< 2.75 mm * Stented lesion * Suspected coronary spasm even after sufficient nitrate injected * Cases in which the IVUS or OCT imaging catheter failed to cross the lesion * Poor quality IVUS or OCT images * Contraindication to dual anti-platelet therapy * Chronic total occlusion * Angiographically large-sized vessel (\>3.5mm of reference lumen diameter) * Life expectancy shorter than 2 years * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OCT-measured in-scaffold minimal lumen area | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| OCT-measured minimal scaffold area (MSA) | 1 year |
| OCT-measured mean scaffold expansion | 1 year |
Countries
South Korea
Outcome results
None listed