KOMATE Registry: Korean Multicenter Angioplasty Team

Coronary Artery Disease Clinical Trial

Official title:

KOMATE Registry: Korean Multicenter Angioplasty Team

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03908463
• Other study ID #: 4-2018-0759
• Status: Recruiting
• Start date: October 5, 2018
• Est. completion date: April 2039

Study information

• Verified date: March 2024
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: April 2039
• Est. primary completion date: April 2039
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Infarction
• Myocardial Infarction
• Percutaneous Coronary Intervention

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion revascularization	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.	Up to 20 years
Primary	Target vessel revascularization	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.	Up to 20 years
Primary	Stent thrombosis	Stent thrombosis is defined and discussed by the Academic Research Consortium	Up to 20 years
Primary	Myocardial infarction	Myocardial Infarction Classification and Criteria for Diagnosis is defined by the Academic Research Consortium	Up to 20 years
Primary	Death	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.	Up to 20 years
Primary	Non-target vessel revascularization	Any revascularization of target-vessel revascularization will be collected.	Up to 20 years
Primary	Cerebrovascular accident	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.	Up to 20 years
Primary	Major bleeding	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.	Up to 20 years
Primary	Cardiovascular readmission	Any readmission due to cardiovascular adverse event will be collected.	Up to 20 years