Assessment of the Utility of the Pantheris Small Vessel (SV) System
A single-arm study to assess the utility of the Pantheris SV catheter in addressing peripheral artery disease in arteries located below the knee. Data will be collected on the percent stenosis pre- and post-atherectomy and then symptoms and adverse events noted at 30 days, 6 months, and 1 year after the procedure.
| Condition(s) | Peripheral Arterial Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | A single-arm study to assess the utility of the Pantheris SV catheter in addressing peripheral artery disease in arteries located below the knee. Data will be collected on the percent stenosis pre- and post-atherectomy and then symptoms and adverse events noted at 30 days, 6 months, and 1 year after the procedure. |
| Who can participate | Inclusion Criteria: * 18 years or older * Target lesion in the infragenicular segment * At least 1 pedal vessel noted in the foot * Rutherford classification 3 to 6 * Willing to give informed consent Exclusion Criteria: * if female, is pregnant or breast feeding * has had surgery or endovascular procedure within 30 days prior to the index procedure * has planned surgery within 30 days after the index procedure * had a major bleeding event within 60 days prior to the index procedure * currently in the treatment phase of a drug or device trial * has anticipated life span of less than 1.5 years * is unwilling to present to the investigator at 30 days, 6 moths, or 1 year after the index procedure |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Avinger, Inc. |
| Locations | Grand Rapids, Michigan, United States; Saint Clair Shores, Michigan, United States |
| Start date | 2021-01-29 |
| NCT ID | NCT04793581 |
| Official listing | https://clinicaltrials.gov/study/NCT04793581 |