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| Name | Class |
|---|---|
| Yale Cardiovascular Research Group | OTHER |
| Julius Clinical | INDUSTRY |
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The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.
The data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects | The study population will consist of subjects with claudication or ischemic rest pain, with de novo or restenotic lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral balloon angioplasty | Device | Serration balloon angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistula |
| Measure | Description | Time Frame |
|---|---|---|
| Performance Endpoint | Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a post- Serranator® residual stenosis of ≤30% by angiographic core laboratory assessment at the intended target lesion. | Peri-procedural |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint | Major Adverse Events (MAE) until discharge, defined as all amputations and any re-intervention (surgical or endovascular) in the target limb. | Peri-procedural |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of subjects with claudication or ischemic rest pain, with de novo or restenotic lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexis Shewfelt | Contact | 6502086743 | ashewfelt33@cagentvascular.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Recruiting | Scottsdale | Arizona | 85251 | United States |
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| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| Hartford HealthCare | Recruiting | Hartford | Connecticut | 06102 | United States |
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| MedStar Washington Hospital / MedStar Montgomery | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Manatee Memorial | Recruiting | Bradenton | Florida | 34208 | United States |
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| Radiology and Imaging Specialists | Recruiting | Lakeland | Florida | 33801 | United States |
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| Henry Ford Health | Recruiting | Detroit | Michigan | 48202 | United States |
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| Barnes Jewish | Recruiting | St Louis | Missouri | 63141 | United States |
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| Atlantic Medical Imaging | Recruiting | Brick | New Jersey | 08724 | United States |
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| Virtua Health | Recruiting | Marlton | New Jersey | 08053 | United States |
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| Northwell | Recruiting | New Hyde Park | New York | 11042 | United States |
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| Ohio State University Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Miami Valley Hospital | Recruiting | Dayton | Ohio | 45409 | United States |
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| Oregon Health & Sciences University | Recruiting | Portland | Oregon | 97239 | United States |
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| Penn Presbyterian Medical Center | Active, not recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Jefferson Einstein | Recruiting | Philadelphia | Pennsylvania | 19141 | United States |
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| Brown Health | Recruiting | Providence | Rhode Island | 02912 | United States |
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| Prisma Health | Recruiting | Greenville | South Carolina | 29615 | United States |
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| Aurora St. Luke's | Recruiting | Milwaukee | Wisconsin | 53215 | United States |
|
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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