KOMATE Registry: Korean Multicenter Angioplasty Team

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

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.

Eligibility

Primary outcome measure(s)

• Target lesion revascularization — 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: 1. A positive history of recurrent angina pectoris, presumably related to the target vessel; 2. Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; 3. Abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve); 4. A TLR or TVR with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms.
• Target vessel revascularization — 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: 1. A positive history of recurrent angina pectoris, presumably related to the target vessel; 2. Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; 3. Abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve); 4. A TLR or TVR with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms.
• Stent thrombosis — Up to 20 years
  Stent thrombosis is defined and discussed by the Academic Research Consortium
• Myocardial infarction — Up to 20 years
  Myocardial Infarction Classification and Criteria for Diagnosis is defined by the Academic Research Consortium
• Death — 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.
• Non-target vessel revascularization — Up to 20 years
  Any revascularization of target-vessel revascularization will be collected.
• Cerebrovascular accident — 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.
• Major bleeding — 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.
• Cardiovascular readmission — Up to 20 years
  Any readmission due to cardiovascular adverse event will be collected.

Trial sites (1)

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