Clinical trial NCT03292081: Comparison Between OFDI and IVUS in PCI Guidance for Biolimus A9 Eluting Stent Implantation
Official title: Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound in Percutaneous Coronary Intervention Guidance for Biolimus A9 Eluting Stent Implantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: Intracoronary Imaging
Optical Frequency Domain Imaging
Intravascular Ultrasound
Percutaneous Coronary Intervention
Drug Eluting Stent
Lead sponsor: Fujita Health University
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Minimum lumen area assessed by OFDI
timeFrame: 8 months
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 8 months
measure: Target vessel myocardial infarction
timeFrame: 8 months
measure: Target lesion revascularization
timeFrame: 8 months
measure: Apposition of stent struts assessed by OFDI
timeFrame: 8 months
measure: Tissue coverage of stent struts assessed by OFDI
timeFrame: 8 months
measure: Quantitative Coronary Angiography (QCA)
timeFrame: 8 months
Other outcomes:
measure: Integrated Backscatter IVUS (IB-IVUS)
timeFrame: 0 month (pre-procedure)
measure: Detectable external elastic lamina (EEL) arc assessed by OFDI
timeFrame: 0 month (pre-procedure)
Locations:
city: Toyoake
country: Japan
facility: Fujita Health University
Study officials:
References:
citation: Muramatsu T, Ozaki Y, Nanasato M, Ishikawa M, Nagasaka R, Ohota M, Hashimoto Y, Yoshiki Y, Takatsu H, Ito K, Kamiya H, Yoshida Y, Murohara T, Izawa H; MISTIC-1 Investigators. Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound for Percutaneous Coronary Intervention Guidance in Biolimus A9-Eluting Stent Implantation: A Randomized MISTIC-1 Non-Inferiority Trial. Circ Cardiovasc Interv. 2020 Nov;13(11):e009314. doi: 10.1161/CIRCINTERVENTIONS.120.009314. Epub 2020 Oct 27.