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

Coronary Artery Disease Clinical Trial

— ACTIV-BVS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02814578
• Other study ID #: AMCCV2016-02
• Status: Terminated
• Phase: N/A
• Start date: July 31, 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: September 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Optical coherent tomography
comparative method for BVS
• IntraVascular UltraSound
The method of goldstandard for decision stent choice

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul	Songpa-Gu
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Young-Hak Kim, MD, PhD	Abbott Vascular

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCT-measured in-scaffold minimal lumen area		1 year
Secondary	OCT-measured minimal scaffold area (MSA)		1 year
Secondary	OCT-measured mean scaffold expansion		1 year