An interventional study of Atherectomy in Peripheral Arterial Disease, sponsored by Avinger, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Avinger, Inc. · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Single-arm study
Device: Atherectomy
Directional atherectomy of lesions below the knee.
Major Adverse Events
freedom from cardiovascular-related events
Time frame: from procedure to 30 days post-procedure
Technical success
defined as residual stenosis \< 50 percent after atherectomy
Time frame: At 1 day post-procedure
Procedure success
defined as residual stenosis \< 30 percent post adjunctive therapy
Time frame: At 1 day post-procedure
Freedom from target vessel revascularization (TVR)
revascularization needed further
Time frame: At 6 and 12 months post-procedure
Primary patency
change in peak systolic velocity ratio (PSVR)
Time frame: At 6 and 12 months post-procedure
Ankle-Brachial Index (ABI)
change since index procedure
Time frame: At 6 and 12 months post-procedure
Rutherford Classificaiton
Change since index procedure
Time frame: At 30 days, 6 months, and 1 year post-procedure
Plan to share: No
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Avinger, Inc.