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Completed

NCT Number: NCT03871127

Ten-Year Outcomes of PRE-COMBAT Trial

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).

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chonnam National University Hospital, Gwangju, South Korea

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About this study

This study is an extended one of PRECOMBAT trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject group enrolled in PRECOMBAT trial

Treatment and study plan

Percutaneous coronary intervention

Procedure

Using sirolimus eluting stent

Coronary artery bypass graft

Procedure

coronary artery bypass graft

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study 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

Acronym: PRECOMBAT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2019
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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