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

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ClinicalTrials.gov Identifier: NCT03292081
Recruitment Status : Active, not recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Yukio Ozaki, Fujita Health University

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
Coronary Artery Disease 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 Type : Interventional  (Clinical Trial)
Estimated 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 : June 12, 2014
Actual Primary Completion Date : July 31, 2016
Estimated Study Completion Date : October 25, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Minimum lumen area assessed by OFDI [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Cardiovascular mortality [ Time Frame: 8 months ]
  2. Target vessel myocardial infarction [ Time Frame: 8 months ]
  3. Target lesion revascularization [ Time Frame: 8 months ]
  4. Apposition of stent struts assessed by OFDI [ Time Frame: 8 months ]
  5. Tissue coverage of stent struts assessed by OFDI [ Time Frame: 8 months ]
  6. Quantitative Coronary Angiography (QCA) [ Time Frame: 8 months ]

Other Outcome Measures:
  1. Integrated Backscatter IVUS (IB-IVUS) [ Time Frame: 0 month (pre-procedure) ]
    Plaque components including lipid pool, fibrosis, dense fibrosis or calcification

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


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292081


Locations
Japan
Fujita Health University
Toyoake, Japan, 470-1192
Sponsors and Collaborators
Fujita Health University

Responsible Party: Yukio Ozaki, Professor, Department of Cardiology, Fujita Health University
ClinicalTrials.gov Identifier: NCT03292081     History of Changes
Other Study ID Numbers: 14-106
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
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, Fujita Health University:
Intracoronary Imaging
Optical Frequency Domain Imaging
Intravascular Ultrasound
Percutaneous Coronary Intervention
Drug Eluting Stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Umirolimus
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs