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

Not Applicable

Terminated

• Conditions: Coronary Artery Disease

• 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

Primary Outcome Measures

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

Secondary Outcome Measures

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