Comparison Between OFDI and IVUS in PCI Guidance for Biolimus A9 Eluting Stent Implantation (MISTIC-1)

Fujita Health University

Status and phase

Unknown

Phase 2

Conditions

Coronary Artery Disease

Treatments

Device: OFDI

Device: IVUS

Study type

Interventional

Funder types

Other

Identifiers

NCT03292081

14-106

Details and patient eligibility

About

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.

Full 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.

Enrollment

96 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.