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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
| CardioVascular Research Foundation, Korea | OTHER |
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This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.
Following angiography, patients with significant diameter stenosis > 50% and lesion length (> 50mm) requiring at least 2 multiple long-stent placement by visual estimation and eligible for LONG-DES VI trial inclusion and exclusion criteria will be randomized 1:1 to zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) by the stratified randomization method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zotarolimus-eluting stent | Active Comparator | Resolute Integrity or Resolute Onyx stent |
|
| everolimus-eluting stent | Experimental | Xience Prime or Xience Xpedition or Xience Alpine stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous coronary intervention | Device | drug eluting stent implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-segment late luminal loss at 13 month follow-up | 13 month post stenting |
| Measure | Description | Time Frame |
|---|---|---|
| 1. All Death | 12 month clinical follow-up | |
| 2. Cardiac death | 12 month clinical follow-up | |
| 3. Myocardial infarction (MI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Jung Park, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangwon National Univ. Hospital | Chuncheon | South Korea | ||||
| Keimyung University Dongsan Medical Center |
This is not a publicly funded trial.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular 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 |
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| 12 month clinical follow-up |
| 4. Composite of death or MI | 12 month clinical follow-up |
| 5. Composite of cardiac death or MI | 12 month clinical follow-up |
| 6. Target vessel revascularization (ischemia-driven and clinically-driven) | 12 month clinical follow-up |
| 7. Target lesion revascularization (ischemia-driven and clinically-driven) | 12 month clinical follow-up |
| 8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) | 12 month clinical follow-up |
| 9. Stent thrombosis (ARC criteria) | 12 month clinical follow-up |
| 10. In-stent late loss | 13 month angiographic follow-up |
| 11. In-stent and in-segment restenosis | 13 month angiographic follow-up |
| 12. Angiographic pattern of restenosis | 13 month angiographic follow-up |
| 13. Volume of intimal hyperplasia | sub-study | 13 month IVUS follow-up |
| 14. Incidence of late stent malapposition | sub-study | 13 month IVUS follow-up |
| 15. Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay | 2-3 days post stenting |
| Daegu |
| South Korea |
| Kyungpook National university hospital | Daegu | South Korea |
| The Catholic University of Korea, Daejeon ST. Mary's Hospital | Daejeon | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| National Health Insurance Service Ilsan Hospital | Ilsan | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Kyunghee University Medical Center | Seoul | South Korea |
| The Catholic University of Korea, Yeouido St. Mary's Hospital | Seoul | South Korea |
| St.carollo Hospital | Suncheon | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | South Korea |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D019060 | Minimally Invasive Surgical Procedures |