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This study evaluates the safety and effectiveness Percutaneous Transluminal Angioplasty(PTA) using Drug-Coated Balloons for the treatment of Superficial Femoral and popliteal peripheral Artery disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IN.PACT drug coated balloon | Active Comparator | IN.PACT drug coated balloon |
|
| Lutonix drug coated balloon | Experimental | Lutonix drug coated balloon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN.PACT drug coated balloon | Device |
| ||
| Lutonix drug coated balloon |
| Measure | Description | Time Frame |
|---|---|---|
| the event rate of composite event | all cause death, revascularization due to amputation or clinical evidence | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| all cause death | 2 years | |
| cardiac death | 2 years | |
| myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang | South Korea | ||||
| Gyeongsang National University Changwon Hospital |
This is not publicly funded trial.
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| Device |
|
| 2 years |
| stroke | 2 years |
| amputation of target limb | 2 years |
| target lesion revascularization | 2 years |
| The change of Rutherford classification | 2 years |
| The change of ABI(ankle-brachial index) score | 2 years |
| MACE | major adverse cardiac event(death, myocardial infarction, stroke) | 2 years |
| thrombosis | 2 years |
| Changwon |
| South Korea |
| Kangwon National University Hospital | Chuncheon | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| Myongji Hospital | Goyang-si | South Korea |
| Seoul national university Bundang hospital | Gyeonggi-do | South Korea |
| Jesushospital | Jeonju | South Korea |
| Dong-A Medical Center | Pusan | South Korea |
| Inje University Pusan Paik Hospital | Pusan | South Korea |
| Veterans Hospital | Pusan | South Korea |
| Chungnam National University Sejong Hospital | Sejong | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Kangbuk Samsung Medical Center | Seoul | South Korea |
| Veterans Hospital Service Medical Center | Seoul | South Korea |