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HCR registry: Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization

Sponsor
Seung-Jung Park (Other)
Overall Status
Recruiting
CT.gov ID
NCT03788369
Collaborator
CardioVascular Research Foundation, Korea (Other)
200
Enrollment
1
Location
139.9
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluated the effectiveness and safety of Hybrid Coronary Revascularization in real-world practice.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Hybrid Coronary Revascularization

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization, a Non-randomized, Prospective, Open-label Registry in Real-world Practice
Actual Study Start Date :
Apr 5, 2019
Anticipated Primary Completion Date :
Jun 1, 2030
Anticipated Study Completion Date :
Dec 1, 2030

Arms and Interventions

Arm Intervention/Treatment
Multivessel coronary artery disease

must include left anterior descending artery

Procedure: Hybrid Coronary Revascularization
Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non-left anterior descending vessels.
Other Names:
  • HCR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. a composite event of death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke. [5 years]

      Patients who have experienced any one of the following events are considered to have experienced the composite outcome: death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke.

    Secondary Outcome Measures

    1. All death [5 years]

    2. Cardiac death [5 years]

    3. Myocardial infarction [5 years]

    4. a composite event of all death or myocardial infarction [5 years]

    5. a composite event of cardiac death or myocardial infarction [5 years]

    6. TVR(Target Vessel Revascularization) [5 years]

    7. TLR(Target Lesion Revascularization) [5 years]

    8. Stent thrombosis [5 years]

      by an Academic Research Consortium (ARC) category

    9. Cerebrovascular event [5 years]

    10. Procedural success [5 days]

      Procedural success is defined as < 30% final stenosis and the absence of in-hospital event including death, Q-wave myocardial infarction or urgent repeat revascularization.

    Eligibility Criteria

    Criteria

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

    • Age 20 and more

    • Hybrid coronary revascularization due to multivessel coronary artery disease(must include left anterior descending artery)

    • Written consent

    Exclusion Criteria:

    • Previous CABG(coronary artery bypass graft)

    • Life expectancy ≤1 year

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seung-Jung Park
    • CardioVascular Research Foundation, Korea

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seung-Jung Park, Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT03788369
    Other Study ID Numbers:
    • AMCCV2018-12
    First Posted:
    Dec 27, 2018
    Last Update Posted:
    Jul 1, 2022
    Last Verified:
    Jun 1, 2022
    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 Seung-Jung Park, Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Asan Medical Center
    Hybrid coronary revascularization
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Coronary Stenosis
    Disease Progression

    Study Results

    No Results Posted as of Jul 1, 2022