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Recruiting

NCT Number: NCT03908463

KOMATE Registry: Korean Multicenter Angioplasty Team

The investigators will enroll the patients who underwent PCI and was based on real world clinical practice to collect the data regarding demographic, clinical, procedural information and clinical outcome using case report forms.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, South Korea

Seoul, South Korea

Location status: Recruiting

Location contact

Byeong-Keuk Kim, PhD

CONTACT

[email protected]

82-2-2228-8460

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Patients older than 19 years
  • 2. Patients who undergo percutaneous coronary intervention

Exclusion criteria

  • 1. Refuse to participate
  • 2. Pregnant women or women with potential childbearing

Treatment and study plan

Percutaneous coronary intervention

Device

All coronary intervention procedures will be performed according to current standard techniques.

Primary outcomes

  1. Target lesion revascularization

    Time frame: Up to 20 years

    Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated or not clinically indicated by the investigator prior to repeat angiography. Clinically indicated revascularization: A revascularization is considered clinically indicated if angiography at followup shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    • A positive history of recurrent angina pectoris, presumably related to the target vessel;
    • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    • Abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve);
    • A TLR or TVR with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms.
  2. Target vessel revascularization

    Time frame: Up to 20 years

    Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated or not clinically indicated by the investigator prior to repeat angiography. Clinically indicated revascularization: A revascularization is considered clinically indicated if angiography at followup shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    • A positive history of recurrent angina pectoris, presumably related to the target vessel;
    • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    • Abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve);
    • A TLR or TVR with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms.
  3. Stent thrombosis

    Time frame: Up to 20 years

    Stent thrombosis is defined and discussed by the Academic Research Consortium

  4. Myocardial infarction

    Time frame: Up to 20 years

    Myocardial Infarction Classification and Criteria for Diagnosis is defined by the Academic Research Consortium

  5. Death

    Time frame: Up to 20 years

    All death will be recorded and their reason also be recorded. Also, cardiac death is defined as death due to myocardial infarction, cardiac perforation, tamponade, arrhythmia or any cardiac cause.

  6. Non-target vessel revascularization

    Time frame: Up to 20 years

    Any revascularization of target-vessel revascularization will be collected.

  7. Cerebrovascular accident

    Time frame: Up to 20 years

    Sudden onset of vertigo, numbness, aphasia, dysarthria or central neurologic deficit secondary to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persist for > 72 hours.

  8. Major bleeding

    Time frame: Up to 20 years

    Any bleeding event will be collected with following description; the amount of hemoglobin drop or transfusion, the site of bleeding, any further treatment for the bleeding.

  9. Cardiovascular readmission

    Time frame: Up to 20 years

    Any readmission due to cardiovascular adverse event will be collected.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2018
Primary completion
2039
Study completion
2039
First posted
Apr 9, 2019
Registry last updated
Mar 19, 2024

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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