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The purpose of this study is to demonstrate the Safety and effectiveness of the use of NMB's drug ejecting balloon for the treatment of de novo and restenotic lesions in peripheral arterial disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | NMB's Paclitaxel Drug ejecting balloon catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMB Balloon Catheter | Device | patients treated by the NMB's Drug Ejecting Balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late Lumen Loss (LLL) | Late Lumen Loss (LLL) defined as the difference between the minimal luminal diameter after the procedure and at 6 months, as evaluated by Quantitative Angiography (mm units will be used) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Restenosis rate | Restenosis is defined as stenosis of at least 50% of the luminal diameter at 6 months | 6 months |
| Device Malfunction | intraprocedural, 3, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eli Atar, MD | Contact | 972-3-9376389 | elia@clalit.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rabin Medical Center, Hasharon Hospital | Petah Tikva | Israel |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Adverse events | intraprocedural, 3, 6 and 12 months |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |