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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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The purpose of this study is to establish the safety and effectiveness of paclitaxel eluting balloon (SeQuent Please) compared to coronary stenting with the Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) in the treatment of drug eluting stent restenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Eluting Stent | Active Comparator | Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) |
|
| paclitaxel eluting balloon | Experimental | paclitaxel eluting balloon (SeQuent Please) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus-eluting balloon expandable stent | Device | Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late luminal loss | Late luminal loss at 9 months angiographic follow-up. | 9months |
| Measure | Description | Time Frame |
|---|---|---|
| Death | 1 year | |
| Myocardial infarction | 1 year | |
| Target lesion revascularization |
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Inclusion Criteria:
Exclusion Criteria:
The patient has a known hypersensitivity or contraindication to any of the following medications:
Systemic (intravenous) Everolimus 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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Songpa-gu | 138-736 | South Korea | ||
| Soon Chun Hyang University Hospital Bucheon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29447782 | Derived | Wong YTA, Kang DY, Lee JB, Rha SW, Hong YJ, Shin ES, Her SH, Nam CW, Chung WY, Kim MH, Lee CH, Lee PH, Ahn JM, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park DW, Park SJ. Comparison of drug-eluting stents and drug-coated balloon for the treatment of drug-eluting coronary stent restenosis: A randomized RESTORE trial. Am Heart J. 2018 Mar;197:35-42. doi: 10.1016/j.ahj.2017.11.008. Epub 2017 Nov 22. |
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| paclitaxel eluting balloon | Device | paclitaxel eluting balloon (SeQuent Please) |
|
| 1 year |
| Target vessel revascularization | 1 year |
| Stent thrombosis | 1 year |
| In-segment or in-stent restenosis at 9 month angiographic follow-up | 1 year |
| Procedural success | defined as achievement of a final diameter stenosis of <30% by QCA(Quantitative Coronary Angiography) using any percutaneous method, without the occurrence of death, Q wave Myocardial Infarction, or repeat revascularization of the target lesion during the hospital stay. participants will be followed for the duration of hospital stay, an expected average of 3days. | 3day |
| Bucheon-si |
| South Korea |
| Chungbuk National University Hospital | Chungjoo | South Korea |
| Daegu Catholic University Medical Center | Daegu | South Korea |
| Keimyung University Dongsan Medical Center | 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 |
| Dong-A Medical Center | Pusan | South Korea |
| Seoul National University Boramae Medical Center | Seoul | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| ID | Term |
|---|---|
| D023903 | Coronary Restenosis |
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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