Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Other: Optical coherent tomography; Other: IntraVascular UltraSound

• Registration Number: NCT02814578
• Lead Sponsor: Young-Hak Kim, MD, PhD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-27
• Study Start: 2017-07-31
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optical coherent tomography	Optical coherent tomography	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	IntraVascular UltraSound	Intravascular ultrasound guidance has been associated with improved event-free survival compared with angiographic guidance after DES placement.

Primary Outcome Measures

Name	Time	Method
OCT-measured in-scaffold minimal lumen area	1 year

Secondary Outcome Measures

Name	Time	Method
OCT-measured mean scaffold expansion	1 year
OCT-measured minimal scaffold area (MSA)	1 year

Trial Locations

Locations (3)

Asan Medical Center; 🇰🇷 Seoul, Songpa-Gu, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of