Comparison Between OFDI and IVUS in PCI Guidance for Biolimus A9 Eluting Stent Implantation

Phase 2

• Conditions: Coronary Artery Disease
• Interventions: Device: OFDI; Device: IVUS

• Registration Number: NCT03292081
• Lead Sponsor: Fujita Health University

Brief Summary

The aim of this study is to assess clinical safety and efficacy of percutaneous coronary intervention (PCI) using a newer generation drug-eluting stent (DES) in the context of optical frequency domain imaging (OFDI) guidance or intravascular ultrasound (IVUS) guidance.

Detailed Description

Intracoronary imaging techniques provide clinically useful information in the setting of PCI, such as lesion severity, tissue characterization, vessel sizing, and stent optimization. Current evidences suggest potential advantage of intracoronary imaging guidance in reducing the risk of major adverse cardiac events after stent implantation over conventional PCI under angiographic guidance alone. IVUS has been clinically used in two decades and it is known as one of the most dominant intracoronary imaging technique. OFDI is a new light-based intracoronary imaging technology which provides higher image resolution and higher-speed pullback compared to those of IVUS. Given the different properties between ultrasound-based IVUS and light-based OFDI, treatment and clinical impact of these two imaging techniques would be different.

Study Timeline

• Study Start: 2014-06-12
• Primary Completion: 2016-07-31
• Study First Submitted: 2017-08-29
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-22
• Last Update Submitted: 2017-09-22
• Study First Posted: 2017-09-25
• Last Update Posted: 2017-09-25
• Study Completion: 2017-10-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Patients with stable coronary artery disease who have symptoms or myocardial ischemia proven by non-invasive or invasive stress test.

Exclusion Criteria

• Renal insufficiency with estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2
• Left ventricular ejection fraction (LVEF) <30% or history of congestive heart failure
• Acute coronary syndrome within 7 days after onset
• Considered as inappropriate for drug-eluting stent (DES) use or dual antiplatelet therapy for one year after the index procedure
• Life expectancy within one year
• Lesion length estimated by quantitative coronary angiography (QCA) >28mm
• Chronic total occlusion
• Left main stem lesion
• Bifurcation requiring side branch balloon dilatation
• Severely calcified lesion
• Other conditions by which physicians in charge judged inappropriate to enroll the patients because of safety concern.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OFDI-guided PCI	OFDI	-
IVUS-guided PCI	IVUS	-

Primary Outcome Measures

Name	Time	Method
Minimum lumen area assessed by OFDI	8 months

Secondary Outcome Measures

Name	Time	Method
Target vessel myocardial infarction	8 months
Target lesion revascularization	8 months
Quantitative Coronary Angiography (QCA)	8 months
Tissue coverage of stent struts assessed by OFDI	8 months
Cardiovascular mortality	8 months
Apposition of stent struts assessed by OFDI	8 months

Trial Locations

Locations (1)

Fujita Health University; 🇯🇵 Toyoake, Japan