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Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels

Primary Purpose

Vasodilation, Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nitrate
Sponsored by
Inha University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasodilation

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Over 19 years old
  • evidence of coronary artery disease including asymptomatic ischemia stable angina acute coronary syndrome (unstable angina, non-ST segment elevation

    • myocardial infarction, ST segment elevation myocardial infarction).
  • coronary artery diameter 2.25~3.5mm, stenosis 50% or more
  • Those who voluntarily agreed in writing to participate in this clinical study

Exclusion Criteria:

  • instability or psychogenic shock within 24 hours before percutaneous coronary intervention
  • life expectancy no longer than 1 year
  • hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel
  • patients whom researchers think unsuitable for participation in this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Nitrate Group

    Control Group

    Arm Description

    with administration of intra-coronary nitrate before percutaneous coronary intervention

    without administration of intra-coronary nitrate before percutaneous coronary intervention

    Outcomes

    Primary Outcome Measures

    Mean stent diameter

    Secondary Outcome Measures

    Failure rate of target lesion for 1-year (combination of cardiac death, target vascular myocardial infarction, target vascular revascularization)

    Full Information

    First Posted
    June 7, 2021
    Last Updated
    June 11, 2021
    Sponsor
    Inha University Hospital
    Collaborators
    Terumo Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04931784
    Brief Title
    Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels
    Official Title
    Prospective, Open, Randomized Study Comparing the Effects of Ultimaster® Stents Treated With Conventional Methods on Coronary Artery Lesions Compared to the Most Dilated Coronary Vessels
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2021 (Anticipated)
    Primary Completion Date
    July 31, 2023 (Anticipated)
    Study Completion Date
    July 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Inha University Hospital
    Collaborators
    Terumo Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In patients with vasospasm or with negative remodeling, various vasodilator drugs used during coronary angiography can dilate the diameter of the reference vessel to measure the exact vessel size. In particular, nitrates are well known to induce pharmacological vasodilatory effects through vascular smooth muscle relaxation In actual clinical practice, it has been reported that when oral or spray-type nitrate preparations are administered to coronary artery stenosis lesions, the diameter of the reference vessel expands by about 10% compared to the existing vessel diameter. This may enable larger stenting in coronary artery stenosis lesions. Although many patients with vascular stenosis are accompanied by vasospasm and voice remodeling, in actual clinical practice, administration of vasodilators is only used in a small number of patients at the discretion of the surgeon. Nitrate vasodilators administered during coronary angiography are low-dose and short-acting drugs, and although a small number of patients may experience side effects such as short-term lowering of blood pressure, no serious side effects are reported . On this background, this study is to evaluate whether there is a difference in the diameter of the Ultimaster® stent treated with the conventional method compared to the maximally dilated coronary artery, and to evaluate the stability and effectiveness after the procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vasodilation, Coronary Artery Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nitrate Group
    Arm Type
    Active Comparator
    Arm Description
    with administration of intra-coronary nitrate before percutaneous coronary intervention
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    without administration of intra-coronary nitrate before percutaneous coronary intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Nitrate
    Other Intervention Name(s)
    No intervention
    Intervention Description
    Administration of intra-coronary nitrate before percutaneous coronary intervention
    Primary Outcome Measure Information:
    Title
    Mean stent diameter
    Time Frame
    Immediately after percutaneous coronary intervention
    Secondary Outcome Measure Information:
    Title
    Failure rate of target lesion for 1-year (combination of cardiac death, target vascular myocardial infarction, target vascular revascularization)
    Time Frame
    1 year after percutaneous coronary intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Over 19 years old evidence of coronary artery disease including asymptomatic ischemia stable angina acute coronary syndrome (unstable angina, non-ST segment elevation myocardial infarction, ST segment elevation myocardial infarction). coronary artery diameter 2.25~3.5mm, stenosis 50% or more Those who voluntarily agreed in writing to participate in this clinical study Exclusion Criteria: instability or psychogenic shock within 24 hours before percutaneous coronary intervention life expectancy no longer than 1 year hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel patients whom researchers think unsuitable for participation in this study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sang-Don Park, Ph.D
    Phone
    821033356991
    Email
    denki1@inha.ac.kr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels

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