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

NCT02814578 | Terminated DMC

• 1 other identifier: AMCCV2016-02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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.

Conditions

Coronary Artery Disease

Keywords

OCT; IVUS; BVS

Outcome Measures

Primary Outcomes (1)

• OCT-measured in-scaffold minimal lumen area

  1 year

Secondary Outcomes (2)

• OCT-measured minimal scaffold area (MSA)

  1 year

• OCT-measured mean scaffold expansion

  1 year

Study Arms (2)

Optical coherent tomography

EXPERIMENTAL

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.

Other: Optical coherent tomography

IntraVascular UltraSound

ACTIVE COMPARATOR

Intravascular ultrasound guidance has been associated with improved event-free survival compared with angiographic guidance after DES placement.

Other: IntraVascular UltraSound

Interventions

Optical coherent tomography OTHER

comparative method for BVS

Optical coherent tomography

IntraVascular UltraSound OTHER

The method of goldstandard for decision stent choice

IntraVascular UltraSound

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Young-Hak Kim, MD, PhD: lead
• Abbott Medical Devices: collaborator

Study Sites (3)

Asan Medical Center

Seoul, Songpa-Gu, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ultrasonography, Interventional

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in medicine

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 27, 2016
• Study Start: July 31, 2017
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)