Assessment of the Utility of the Pantheris Small Vessel (SV) System
Purpose
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
- Peripheral Arterial Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Single-arm
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Single Arm |
Single-arm study |
|
Recruiting Locations
Grand Rapids, Michigan 49525
Saint Clair Shores, Michigan 48080
More Details
- NCT ID
- NCT04793581
- Status
- Recruiting
- Sponsor
- Avinger, Inc.
Detailed Description
This is a post-market, single-arm study of the optical coherence tomography (OCT)-guided directional atherectomy catheter, Pantheris SV. Patients presenting with reduced blood flow in the lower extremity arteries will under directional atherectomy, followed by adjunctive therapy as deemed necessary by the physician, and then adverse events and symptom resolution will be documented at 30 days, 6 months, and 1 year after the procedure. Primary safety endpoints are related to adverse events and will be assessed at the time of the procedure and at 30 days after the procedure. Effectiveness endpoints center on restoration of blood flow.