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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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To evaluate the best therapeutic option for the treatment of diffuse type post-drug-eluting stent restenosis.
Despite a significant reduction of angiographic restenosis and the need for repeat revascularization after introduction of DES, post-DES restenosis still occur and the treatment for DES failure is challenging. However, there have been little data for therapeutic strategy for post-DES restenosis, especially diffuse type ISR. Therefore, we need the well-designed randomized trial to achieve the best therapeutic option for the treatment of diffuse type post-DES restenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cypher | Experimental | sirolimus-eluting stent |
|
| Xience-V | Active Comparator | everolimus-eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cypher | Device | sirolimus-eluting stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binary in-segment angiographic restenosis | at 9 months angiographic follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| The composite of death, myocardial infarction, and target-vessel revascularization | in-hospital, 1 month, and 9 months after index procedure | |
| stent thrombosis | in-hospital, 1 month, and 9 months after index procedure |
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Inclusion Criteria:
Exclusion Criteria:
The patient has a known hypersensitivity or contraindication to any of the following medications:
Systemic (intravenous) Sirolimus use within 12 months.
Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Patients with EF<30%.
Acute MI patients within symptom onset < 12 hours needing primary angioplasty
Creatinine level 3.0mg/dL or dependence on dialysis.
Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
Patients with left main stem stenosis and left main in-stent restenosis created by DES(>50% by visual estimate)
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Jung Park, MD, PhD | Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Bucheon Hospital | Bucheon-si | South Korea | ||||
| Choeng Ju St.Mary's Hospital |
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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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| Xience-V | Device | everolimus-eluting stent |
|
|
| Late luminal loss | at 8 month angiographic follow-up |
| 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 |
| Choeng Ju |
| South Korea |
| Kangwon National University Hospital | Chuncheon | South Korea |
| Asan Medical Center | Gangneung | South Korea |
| DongGuk University Gyongju Hospital | Gyongju | South Korea |
| Chonbuk National University Hospital | Jeonju | South Korea |
| Kwangju Christian Hospital | Kwangju | South Korea |
| Inje University Pusan Paik Hospital | Pusan | South Korea |
| Hallym University Sacred Heart Hospital, | Pyeongchon | South Korea |
| Hallym University Sacred Heart Hospital | Pyeongchon | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Hangang Sacred Heart Hospital | Seoul | South Korea |
| Kyungsang University Hospital | Seoul | South Korea |
| Seoul Veterans Hospital | Seoul | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |