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Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization (HCR registry)

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ClinicalTrials.gov Identifier: NCT03788369
Recruitment Status : Not yet recruiting
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

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

Condition or disease Intervention/treatment
Percutaneous Coronary Revascularization Coronary Stenosis Coronary Artery Disease Progression Coronary Artery Bypass Grafting Procedure: Hybrid Coronary Revascularization

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Study Type : Observational
Estimated 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
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : June 2030
Estimated Study Completion Date : December 2030

Group/Cohort 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 Name: HCR




Primary Outcome Measures :
  1. a composite event of death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke. [ Time Frame: 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 [ Time Frame: 5 years ]
  2. Cardiac death [ Time Frame: 5 years ]
  3. Myocardial infarction [ Time Frame: 5 years ]
  4. a composite event of all death or myocardial infarction [ Time Frame: 5 years ]
  5. a composite event of cardiac death or myocardial infarction [ Time Frame: 5 years ]
  6. TVR(Target Vessel Revascularization) [ Time Frame: 5 years ]
  7. TLR(Target Lesion Revascularization) [ Time Frame: 5 years ]
  8. Stent thrombosis [ Time Frame: 5 years ]
    by an Academic Research Consortium (ARC) category

  9. Cerebrovascular event [ Time Frame: 5 years ]
  10. Procedural success [ Time Frame: 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with hybrid coronary revascularization due to multivessel coronary artery disease(must include left anterior descending artery)
Criteria

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

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): NCT03788369


Contacts
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Contact: Do-yoon Kang, MD kdy1218@gmail.com

Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea

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Responsible Party: Seung-Jung Park, Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03788369     History of Changes
Other Study ID Numbers: AMCCV2018-12
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seung-Jung Park, Asan Medical Center:
Hybrid coronary revascularization

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Disease Progression
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes