Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Product not available, study withdrawn
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® Alto in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.
Single Arm, multi-center, device registry study capturing de-identified data on a minimum of 100 subjects with peripheral artery disease (PAD) and/or dysfunctional native or synthetic arteriovenous dialysis fistulae. The study will capture acute angiographic data.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAD |
| ||
| AV Fistula |
| ||
| AV Graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serranator® Alto | Device | Serranator® Alto PTA Serration Balloon Catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance | Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a diameter stenosis of <50% by visual assessment at the intended target site after using the Serranator® device. | The registry will collect acute procedural data through hospital discharge, no additional follow up is required. Performance data will be summarized after enrollment is complete, estimated to be 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of device related Major Adverse Events (MAE) until discharge | Safety defined as incidence of device related MAE, defined as amputations or re-interventions (surgical or endovascular) | Within 12-24 hours post-procedure or prior to hospital discharge, whichever occurs first |
Not provided
Not provided
Not provided
Not provided
Not provided
The study population will consist of subjects with claudication or ischemic rest pain, requiring dilatation of lesions, in the iliac or femoropopliteal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D016157 | Vascular Fistula |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |