Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation (ACTIV-BVS)

Young-Hak Kim, MD, PhD

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Other: IntraVascular UltraSound; Other: Optical coherent tomography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02814578

AMCCV2016-02

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

9 participants in 2 patient groups

Optical coherent tomography

Experimental group

Description:

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.

Treatment:

Other: Optical coherent tomography

IntraVascular UltraSound

Active Comparator group

Description:

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

Treatment:

Other: IntraVascular UltraSound