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

Sponsor
Fujita Health University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03292081
Collaborator
(none)
96
Enrollment
1
Location
2
Arms
40.4
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: OFDI
  • Device: IVUS
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound in Percutaneous Coronary Intervention Guidance for Biolimus A9 Eluting Stent Implantation
Actual Study Start Date :
Jun 12, 2014
Actual Primary Completion Date :
Jul 31, 2016
Anticipated Study Completion Date :
Oct 25, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Minimum lumen area assessed by OFDI [8 months]

    Secondary Outcome Measures

    1. Cardiovascular mortality [8 months]

    2. Target vessel myocardial infarction [8 months]

    3. Target lesion revascularization [8 months]

    4. Apposition of stent struts assessed by OFDI [8 months]

    5. Tissue coverage of stent struts assessed by OFDI [8 months]

    6. Quantitative Coronary Angiography (QCA) [8 months]

    Other Outcome Measures

    1. Integrated Backscatter IVUS (IB-IVUS) [0 month (pre-procedure)]

      Plaque components including lipid pool, fibrosis, dense fibrosis or calcification

    2. Detectable external elastic lamina (EEL) arc assessed by OFDI [0 month (pre-procedure)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fujita Health University Toyoake Japan 470-1192

    Sponsors and Collaborators

    • Fujita Health University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yukio Ozaki, Professor, Department of Cardiology, Fujita Health University
    ClinicalTrials.gov Identifier:
    NCT03292081
    Other Study ID Numbers:
    • 14-106
    First Posted:
    Sep 25, 2017
    Last Update Posted:
    Sep 25, 2017
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yukio Ozaki, Professor, Department of Cardiology, Fujita Health University
    Intracoronary Imaging
    Optical Frequency Domain Imaging
    Intravascular Ultrasound
    Percutaneous Coronary Intervention
    Drug Eluting Stent
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Sep 25, 2017