Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation (ACTIV-BVS)
Coronary Artery Disease
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring OCT, IVUS, BVS
Eligibility Criteria
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
Sites / Locations
- Asan Medical Center
- Pusan National University Hospital
- Ulsan University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Optical coherent tomography
IntraVascular UltraSound
Optical coherent tomography provides more detailed information about the morphology of scaffolds, microstructures and coronary vasculature based on tissue characteristics as compared to conventional IVUS. In spite of angiographic success in BVS placement, further scaffold optimization was required in over a quarter of cases based on OCT findings due to malapposition or scaffold under expansion.
Intravascular ultrasound guidance has been associated with improved event-free survival compared with angiographic guidance after DES placement.