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The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) Balloon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMB's PTA Balloon catheter with paclitaxel | Experimental |
| |
| Standard Angioplasty Balloon | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTA Balloon catheter with paclitaxel | Device | patients treated by the NMB's PTA Balloon catheter with paclitaxel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Restenosis Rate | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Restenosis rate | 1,3 and 12 months | |
| Easy insertion and removal | intraprocedural | |
| Major adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uri Rimon, MD | Contact | 972-3-5302530 | Uri.Rimon@sheba.health.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chaim Sheba Medical Center | Tel Litwinsky | Israel |
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| Plain Balloon angioplasty (PBA) | Procedure | PBA |
|
| intraprocedural, 1, 3, 6 and 12 months |