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Ten-Year Outcomes of PRE-COMBAT Trial (PRECOMBAT)

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ClinicalTrials.gov Identifier: NCT03871127
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : June 18, 2020
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

Brief Summary:
This study evaluates Ten-Year Outcomes of PREmier of Randomized Comparison of Sirolimus-Eluting Stent Implantation Versus Coronary Artery Bypass Surgery for Unprotected Left Main Coronary Artery Stenosis(PRECOMBAT trial).

Condition or disease Intervention/treatment
Coronary Artery Disease Procedure: Percutaneous coronary intervention Procedure: coronary artery bypass graft

Detailed Description:
This study is an extended one of PRECOMBAT trial.

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Ten-Year Outcomes of PREmier of Randomized Comparison of Sirolimus-Eluting Stent Implantation Versus Coronary Artery Bypass Surgery for Unprotected Left Main Coronary Artery Stenosis: PRE-COMBAT Trial
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : February 24, 2020
Actual Study Completion Date : February 24, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Left main coronary disease Procedure: Percutaneous coronary intervention
Using sirolimus eluting stent

Procedure: coronary artery bypass graft
coronary artery bypass graft




Primary Outcome Measures :
  1. Composite outcome [ Time Frame: 10 year ]
    The composite of death, myocardial infarction, and revascularization. Patients who have experienced any one of the following events are considered to have experienced the composite outcome: death, myocardial infarction, and revascularization


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 10 year ]
  2. Cardiac death [ Time Frame: 10 year ]
  3. Myocardial infarction [ Time Frame: 10 year ]
  4. Cerebrovascular accident [ Time Frame: 10 year ]
  5. Target vessel revascularization [ Time Frame: 10 year ]
  6. Target lesion revascularization [ Time Frame: 10 year ]
  7. Stent thrombosis [ Time Frame: 10 year ]
  8. Binary restenosis in both in-stent and in-segment [ Time Frame: 10 year ]
  9. Graft reocclusion rate [ Time Frame: 10 year ]
  10. Graft patency rate [ Time Frame: 10 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subject group enrolled in PRECOMBAT trial
Criteria

Inclusion Criteria:

  • Subject group enrolled in PRECOMBAT trial

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): NCT03871127


Locations
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Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Seoul National University Bundang hospital
Seongnam, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seung-Jung Park, Professor, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03871127    
Other Study ID Numbers: AMCCV2019-02
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
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:
PCI
CABG
Left main
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases