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

Coronary Artery Disease Clinical Trial

— MISTIC-1  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03292081
• Other study ID #: 14-106
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 29, 2017
• Last updated: September 22, 2017
• Start date: June 12, 2014
• Est. completion date: October 25, 2017

Study information

• Verified date: September 2017
• Source: Fujita Health University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: October 25, 2017
• Est. primary completion date: July 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• OFDI
PCI under OFDI guidance
• IVUS
PCI under IVUS guidance

Locations

Country	Name	City	State
Japan	Fujita Health University	Toyoake

Sponsors (1)

Lead Sponsor	Collaborator
Fujita Health University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Integrated Backscatter IVUS (IB-IVUS)	Plaque components including lipid pool, fibrosis, dense fibrosis or calcification	0 month (pre-procedure)
Other	Detectable external elastic lamina (EEL) arc assessed by OFDI		0 month (pre-procedure)
Primary	Minimum lumen area assessed by OFDI		8 months
Secondary	Cardiovascular mortality		8 months
Secondary	Target vessel myocardial infarction		8 months
Secondary	Target lesion revascularization		8 months
Secondary	Apposition of stent struts assessed by OFDI		8 months
Secondary	Tissue coverage of stent struts assessed by OFDI		8 months
Secondary	Quantitative Coronary Angiography (QCA)		8 months