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

Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound in Percutaneous Coronary Intervention Guidance for Biolimus A9 Eluting Stent Implantation

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: OFDI; Device: IVUS

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 Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Toyoake, Japan, 470-1192
    • Fujita Health University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OFDI-guided PCI	Device: OFDI; PCI under OFDI guidance; Other Names: LUNAWAVE imaging console; Fastview imaging catheter
ACTIVE_COMPARATOR: IVUS-guided PCI	Device: IVUS; PCI under IVUS guidance; Other Names: VISIWAVE imaging console; ViewIT imaging catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Minimum lumen area assessed by OFDI	8 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Integrated Backscatter IVUS (IB-IVUS)	Plaque components including lipid pool, fibrosis, dense fibrosis or calcification	0 month (pre-procedure)
Detectable external elastic lamina (EEL) arc assessed by OFDI		0 month (pre-procedure)

Collaborators and Investigators

• Sponsor: Fujita Health University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2014
• Primary Completion (ACTUAL): July 31, 2016
• Study Completion (ANTICIPATED): October 25, 2017

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (ACTUAL): September 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 22, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Drug Eluting Stent; Optical Frequency Domain Imaging; Intravascular Ultrasound; Intracoronary Imaging
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 14-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No