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This single-centre, single-arm, prospective study will enroll 30 subjects presenting with clinical and hemodynamic abnormalities in arteriovenous graft (AVG) in the arm. Subjects will be treated with the Jetstreamâ„¢ atherectomy device and Rangerâ„¢ Drug Coated Balloons (DCB). Subjects will be followed up clinically via office visit or phone visit at 6 and 12 months post procedure. This study is to demonstrate safety and assess the clinical use and outcomes of the Jetstream â„¢atherectomy device and Rangerâ„¢ DCB for the treatment of dysfunctional AV graft.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysfunction AV graft | Experimental | Dysfunctional AV graft stenosis treated with atherectomy and drug coated balloon angioplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atherectomy and balloon angioplasty | Device | Atherectomy and balloon angioplasty of arterial-venous graft stenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Primary Patency (TLPP) through 6 months | 50% re-stenosis of the target lesion | within 6 months post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kong Teng Tan, MD | Contact | 416-340-4800 | 6166 | kongteng.tan@uhn.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Recruiting | Toronto | Ontario | M5G 2N2 | Canada |
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| ID | Term |
|---|---|
| D017073 | Atherectomy |
| D000800 | Angioplasty, Balloon |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
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Treatment of Jetstreamâ„¢ atherectomy device and Ranger â„¢ drug coated balloons
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| D014656 |
| Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |