Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
Not provided
Not provided
Not provided
Not provided
The primary purpose of the study was to determine whether the 2-year probability of major adverse cardiac events (primary composite outcome) differed significantly between patients who underwent angiography-guided Percutaneous Coronary Intervention(PCI) and those who underwent Fractional Flow Reserve(FFR)-guided PCI in patients with Left Main Coronary Artery disease(LMCA).
All participants will be monitored over a span of two years and the time point of the year of last subject last visit. The term "year of last subject last visit" refers to the time point of the last visit for all participants. At this specific time point, event occurrence check will be conducted to determine the occurrence of endpoint events among all participants.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFR-guided Left Main PCI | Experimental |
| |
| Angiography-Guided PCI | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR-Guided PCI | Procedure | Fractional Flow Reserve-Guided PCI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The composite event rate | Composite event consists of death from any causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, or repeat revascularization. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The event rate of death from any causes | 2 years | |
| The event rate of myocardial infarction | any, spontaneous or procedural myocardial infarction | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1) Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial.
2) Screening failed before any interventional factor is involved.
3) Participated in academic trials like strategic comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Duk-woo Park, MD | Contact | dwpark@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Duk-woo Park, MD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margret Hospital( HongKong) | Not yet recruiting | Hong Kong | Hong Kong |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Angiography-Guided PCI |
| Procedure |
Angiography-Guided PCI |
|
| The event rate of hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest | 2 years |
| The event rate of repeat revascularization | 2 years |
| The composite event rate of death or myocardial infarction | 2 years |
| The event rate of stent thrombosis | Stent thrombosis by Academic Research Consortium (ARC) definition | 2 years |
| The event rate of stroke | 2 years |
| The event rate of bleeding complications | Bleeding Academic Research Consortium [BARC] type 3-5, which indicates severe bleeding | 2 years |
| Procedure time | 1 day |
| Amount of contrast agent used | 1 day |
| Length of hospital stay | an average of 7 day |
| The event rate of rehospitalization | Rehospitalization from any, cardiac, or noncardiac causes | 2 years |
| Functional class | Functional class assessed by the Canadian Cardiovascular Society (CCS) Angina Score classification. The minimum and maximum values are I and IV respectively and a higher score means a worse outcome. | 7 days(discharge) and 1, 6, 12, 24 months |
| Change of angina-related quality of life index | By the Seattle Angina Questionnaire [SAQ]. the SAQ is a disease-specific patient-reported outcome (PRO) with 5 domains. Lower score represents poor health status and high score represents good health status. | 7 days(discharge) and 1, 6, 12, 24 months |
| Change of health-related quality of life index | By the EQ-5D. EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group. Range 0 - 1 and a higher score of EQ-5D mean low quality of life. | 7 days(discharge) and 1, 6, 12, 24 months |
| Number of anti-anginal medications | 7 days(discharge) and 1, 6, 12, 24 months |
| Queen Mary Hospital | Not yet recruiting | Hong Kong | Hong Kong |
|
| Manipal Hospital | Recruiting | Bangalore | India |
|
| Japanese Red Cross Musashino Hospital | Recruiting | Tokyo | Japan |
|
| NTT East Japan Kanto Hospital | Withdrawn | Tokyo | Japan |
| Tsuchiura Kyodo General Hospital | Recruiting | Tsuchiura | Japan |
|
| Asan Medical Center | Recruiting | Seoul | Songpa-gu | 138-736 | South Korea |
|
| Korea University Ansan Hospital | Terminated | Ansan | South Korea |
| Hallym University Sacred Heart Hospital | Recruiting | Anyang | South Korea |
|
| Bucheon Sejong Hospital | Recruiting | Bucheon-si | South Korea |
|
| Dong-A University Hospital | Recruiting | Busan | South Korea |
|
| Pusan National University Hospital | Recruiting | Busan | South Korea |
|
| Pusan National University Yangsan Hospital | Terminated | Busan | South Korea |
| Changwon Gyeongsang National University Hospital | Recruiting | Changwon | South Korea |
|
| Kangwon National University Hospital | Recruiting | Chuncheon | South Korea |
|
| Daegu Catholic University Medical Center | Recruiting | Daegu | South Korea |
|
| Keimyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
|
| Yeungnam University Hospital | Recruiting | Daegu | South Korea |
|
| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
|
| Daejeon St. Mary's Hospital, Catholic University of Korea | Recruiting | Daejeon | South Korea |
|
| Gangneung Asan Hospital | Recruiting | Gangneung | South Korea |
|
| Chonnam National University Hospital | Recruiting | Gwangju | South Korea |
|
| Chung-Ang University Gwangmyeong Hospital | Recruiting | Gwangmyeong | South Korea |
|
| Hallym University Dongtan Sacred Heart Hospital | Recruiting | Hwaseong-si | South Korea |
|
| CHA Ilsan Medical Center | Terminated | Ilsan | South Korea |
| Ilsan Myongji Hospital | Terminated | Ilsan | South Korea |
| Inje University Ilsan Paik Hospital | Not yet recruiting | Ilsan | South Korea |
|
| National Health Insurance Service Ilsan Hospital | Recruiting | Ilsan | South Korea |
|
| Gachon University Gil Medical Center | Recruiting | Incheon | South Korea |
|
| Inha University Hospital | Recruiting | Incheon | South Korea |
|
| Jeju National University Hospital | Terminated | Jeju City | South Korea |
| Chungnam National University Sejong Hospital | Recruiting | Seongam | South Korea |
|
| Seoul National University Bundang Hospital | Recruiting | Seongnam | South Korea |
|
| Chung-Ang University Hospital | Recruiting | Seoul | South Korea |
|
| Eunpyeong St. Mary's Hospital, Catholic University of Korea | Recruiting | Seoul | South Korea |
|
| Hanyang University Hospital | Recruiting | Seoul | South Korea |
|
| Kangbuk Samsung Hospital | Not yet recruiting | Seoul | South Korea |
|
| Korea University Anam Hospital | Terminated | Seoul | South Korea |
| Korea University Guro Hospital | Recruiting | Seoul | South Korea |
|
| Kyung Hee University Hospital | Recruiting | Seoul | South Korea |
|
| Seoul Metropolitan Boramae Hospital | Recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| Soonchunhyang University Seoul Hospital | Recruiting | Seoul | South Korea |
|
| Yeouido St. Mary's Hospital, Catholic University of Korea | Recruiting | Seoul | South Korea |
|
| Ajou University Hospital | Recruiting | Suwon | South Korea |
|
| St. Vincent's Hospital, Catholic University of Korea | Recruiting | Suwon | South Korea |
|
| Ulsan University Hospital | Recruiting | Ulsan | South Korea |
|
| Yongin Severance Hospital | Recruiting | Yongin | South Korea |
|
| Cheng Hsin General Hospital | Recruiting | Taipei | Taiwan |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided