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In recent years the use of paclitaxel releasing percutaneous transluminal angioplastic (PTA) balloon catheter is spreading in vascular pathology, mainly in stenosis infrainguinal arteries. This device combined the mechanical action of PTA balloon with the antiproliferative effects of paclitaxel. The use of these devices in venous pathology is limited. This devices could improve the treatment of renal dialysis arteriovenous fistula stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel-releasing PTA balloon catheter | Experimental | Treatment of renal dialysis arteriovenous fistula stenosis with paclitaxel-releasing percutaneous transluminal angioplastic (PTA) balloon catheter. |
|
| PTA Balloon catheter | Active Comparator | Treatment of renal dialysis arteriovenous fistula stenosis with percutaneous transluminal angioplastic (PTA) balloon catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel-releasing PTA balloon catheter | Device |
| ||
| PTA balloon catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from target lesion revascularization | Percentage of patients that do not need any revascularization proceeding during the following twelve months after catheter insertion. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerto Real | Puerto Real | Cádiz | 11510 | Spain | ||
| Hospital Universitario Reina Sofía |
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| Device |
|
| Córdoba |
| 14004 |
| Spain |
| Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital Universitario Juan Ramón Jiménez | Huelva | 21005 | Spain |