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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) for the treatment of obstructive lesions of Arteriovenous (AV) Dialysis Fistulae/Grafts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | NMB's PTA Balloon catheter with Paclitaxel drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMB Paclitaxel Drug Ejecting Balloon | Device | NMB's PTA Balloon catheter with drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Restenosis rate | Binary Stenosis is defined as ≥50% narrowing in luminal diameter basen upon comparison with the adjacent normal vessel. Restenosis Rate - comparison shall be performed both to the patient previous data as well as to restenosis rate data published in the literature for standard PTA balloon catheter procedure | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| restenosis rate | As defined above in the primary end point | 1, 3 and 12 months |
| Easy insertion and removal | intraprocedural | |
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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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| Major adverse events rate |
All adverse events will be reviewed by the Investigator and evaluated as follows:
|
| intraprocedural 1, 3, 6 and 12 months |