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Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels

Sponsor
Inha University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04931784
Collaborator
Terumo Corporation (Industry)
400
Enrollment
2
Arms
36
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Nitrate Group

with administration of intra-coronary nitrate before percutaneous coronary intervention

Drug: Nitrate
Administration of intra-coronary nitrate before percutaneous coronary intervention
Other Names:
  • No intervention

    		•
    Placebo Comparator: Control Group

    without administration of intra-coronary nitrate before percutaneous coronary intervention

    Drug: Nitrate
    Administration of intra-coronary nitrate before percutaneous coronary intervention
    Other Names:
  • No intervention

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean stent diameter [Immediately after percutaneous coronary intervention]

    Secondary Outcome Measures

    1. Failure rate of target lesion for 1-year (combination of cardiac death, target vascular myocardial infarction, target vascular revascularization) [1 year after percutaneous coronary intervention]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Inha University Hospital
    • Terumo Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sang-Don Park, Associate Professor, Inha University Hospital
    ClinicalTrials.gov Identifier:
    NCT04931784
    Other Study ID Numbers:
    • INHAUH 2018-03-009
    First Posted:
    Jun 18, 2021
    Last Update Posted:
    Jun 18, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Jun 18, 2021