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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
OFDI
IVUS
Sponsored by
Fujita Health University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Intracoronary Imaging, Optical Frequency Domain Imaging, Intravascular Ultrasound, Percutaneous Coronary Intervention, Drug Eluting Stent

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fujita Health University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OFDI-guided PCI

IVUS-guided PCI

Arm Description

Outcomes

Primary Outcome Measures

Minimum lumen area assessed by OFDI

Secondary Outcome Measures

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

Full Information

First Posted
August 29, 2017
Last Updated
September 22, 2017
Sponsor
Fujita Health University
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1. Study Identification

Unique Protocol Identification Number
NCT03292081
Brief Title
Comparison Between OFDI and IVUS in PCI Guidance for Biolimus A9 Eluting Stent Implantation
Acronym
MISTIC-1
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 12, 2014 (Actual)
Primary Completion Date
July 31, 2016 (Actual)
Study Completion Date
October 25, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujita Health University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Intracoronary Imaging, Optical Frequency Domain Imaging, Intravascular Ultrasound, Percutaneous Coronary Intervention, Drug Eluting Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OFDI-guided PCI
Arm Type
Experimental
Arm Title
IVUS-guided PCI
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
OFDI
Other Intervention Name(s)
LUNAWAVE imaging console, Fastview imaging catheter
Intervention Description
PCI under OFDI guidance
Intervention Type
Device
Intervention Name(s)
IVUS
Other Intervention Name(s)
VISIWAVE imaging console, ViewIT imaging catheter
Intervention Description
PCI under IVUS guidance
Primary Outcome Measure Information:
Title
Minimum lumen area assessed by OFDI
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Cardiovascular mortality
Time Frame
8 months
Title
Target vessel myocardial infarction
Time Frame
8 months
Title
Target lesion revascularization
Time Frame
8 months
Title
Apposition of stent struts assessed by OFDI
Time Frame
8 months
Title
Tissue coverage of stent struts assessed by OFDI
Time Frame
8 months
Title
Quantitative Coronary Angiography (QCA)
Time Frame
8 months
Other Pre-specified Outcome Measures:
Title
Integrated Backscatter IVUS (IB-IVUS)
Description
Plaque components including lipid pool, fibrosis, dense fibrosis or calcification
Time Frame
0 month (pre-procedure)
Title
Detectable external elastic lamina (EEL) arc assessed by OFDI
Time Frame
0 month (pre-procedure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Fujita Health University
City
Toyoake
ZIP/Postal Code
470-1192
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33106049
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.
Results Reference
derived

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

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