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| Name | Class |
|---|---|
| Biotronik Korea Co., Ltd | INDUSTRY |
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This study is to compare clinical outcomes between quantitative coronary angiography-guided anatomic complete revascularization and fractional flow reserve-guided physiologic complete revascularization in patients with significant coronary artery disease undergoing percutaneous coronary intervention with drug eluting stent
This is a prospective, multicenter center, open-label, randomized trial to compare QCA-guided versus FFR-guided CR strategies in patients with significant CAD who are undergoing PCI with DES. Patients with symptoms or evidence of myocardial ischemia are eligible for enrollment if there have stenotic lesions with a diameter stenosis of 50%-90% in major epicardial coronary arteries ≥ 2.25 mm in diameter by visual estimation, and CR is expected to be achievable by PCI. The detailed information for inclusion and exclusion criteria is described below in the session 4. Patients meeting inclusion criteria without any exclusion criteria will be randomized to either QCA-guided CR or FFR-guided CR group. In the QCA-guided CR group, PCI will be performed if there are lesions with diameter stenosis ≥ 50% by QCA during the index procedure (and, if necessary, planned staged procedure). In the FFR-guided CR group, FFR is measured for the target coronary lesions, and then PCI will be performed for the lesions with FFR ≤0.80. Post-PCI FFR measurement is strongly recommended. However, additional procedures are not recommended based on post-PCI FFR value because there is no consensus of the optimal cut-off value to define physiologic CR. In both QCA-guided and FFR-guided PCI groups, imaging guidance during PCI is left at the discretion of the operator. However, routine high pressure post-dilation with noncompliant balloons is recommended to achieve optimal stent expansion with minimal residual stenosis (diameter stenosis < 10% on visual estimation). Patients will be followed clinically at 1, 6, 12 months, and then upto 5 years after the index procedure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| quantitative coronary angiography-guided percutaneous coronary intervention | Experimental | Successful revascularization of all coronary artery lesions or segments ≥2.25 mm* in diameter with ≥50% diameter stenosis by QCA regardless of their functional significance |
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| fractional flow reserve-guided PCI | Active Comparator | Successful revascularization of all coronary artery lesions or segments ≥2.25 mm in diameter with evidence of ischemia or hemodynamic significance by FFR ≤ 0.80 regardless of their anatomic severity†|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention | Procedure | Percutaneous Coronary Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with death | Major adverse cardiac events are defined as all-cause death | 12month |
| Number of Participants with MI | Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI. | 12month |
| Number of Participants with unplanned repeat revascularization | Unplanned repeat revascularization is defined as revascularization of any diseased coronary arteries ≥ 2.0 mm in diameter by QCA due to recurred angina with at least one of the following: (1) positive non-invasive test, (2) positive invasive physiologic test, or (3) presence of diameter stenosis ≥50% by QCA. | 12month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with death | Major adverse cardiac events are defined as all-cause death | 5years |
| Number of Participants with MI | Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiwon Baek, RN | Contact | 82230107267 | cvcrc22@amc.seoul.kr | |
| Seung-Whan Lee, Investigator | Contact | 82230103170 | seungwlee@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Seung-Whan Lee, Investigator | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Not yet recruiting | Anyang | South Korea |
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| 5years |
| Number of Participants with unplanned repeat revascularization | Unplanned repeat revascularization is defined as revascularization of any diseased coronary arteries ≥ 2.0 mm in diameter by QCA due to recurred angina with at least one of the following: (1) positive non-invasive test, (2) positive invasive physiologic test, or (3) presence of diameter stenosis ≥50% by QCA. | 5years |
| Number of Participants with bleeding | Major or minor bleeding according to definitions from TIMI | 5years |
| Number of Participants with rehospitalization | Rehospitalization for an acute coronary syndrome or repeat PCI | 5years |
| Self-rated health on a vertical visual analogue scale by EQ5D | EQ-5D is a standardized measure of health-related quality of life developed by the EuroQol Group and provides a simple and general questionnaire for use in clinical assessments | 5years |
| cost-effectiveness | Procedure-related cost during index procedure | 5years |
| Bucheon Sejong Hospital | Not yet recruiting | Bucheon-si | South Korea |
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| Inje University Busan Paik Hospital | Recruiting | Busan | South Korea |
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| Gyeongsang National University Changwon Hospital | Recruiting | Changwon | South Korea |
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| Chungbuk National University Hospital | Recruiting | Cheongju-si | South Korea |
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| Daegu Veterans Hospital | Recruiting | Daegu | South Korea |
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| Keimyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
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| Gangneung Asan Hospital | Recruiting | Gangneung | South Korea |
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| Wonkwang University Hospital | Recruiting | Iksan | South Korea |
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| Kwangju Christian Hospital | Recruiting | Kwangju | South Korea |
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| Inje University Pusan Paik Hospital | Recruiting | Pusan | South Korea |
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| Bundang CHA Hospital | Not yet recruiting | Seongnam | South Korea |
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| Asan Medical Center | Recruiting | Seoul | South Korea |
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| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
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| Veterans Hospital Service Medical Center | Recruiting | Seoul | South Korea |
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| The Catholic University of Korea, ST. Vincent's Hospital | Not yet recruiting | Suwon | South Korea |
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| Pusan National University Yangsan Hospital | Not yet recruiting | Yangsan | South Korea |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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