Clinical trial NCT04793581: Assessment of the Utility of the Pantheris Small Vessel (SV) System
Official title: Assessment of the Utility of the Pantheris SV System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: peripheral artery disease (PAD) below-the-knee atherectomy
Lead sponsor: Avinger, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Events
timeFrame: from procedure to 30 days post-procedure
measure: Technical success
timeFrame: At 1 day post-procedure
Secondary outcomes:
measure: Procedure success
timeFrame: At 1 day post-procedure
measure: Freedom from target vessel revascularization (TVR)
timeFrame: At 6 and 12 months post-procedure
measure: Primary patency
timeFrame: At 6 and 12 months post-procedure
measure: Ankle-Brachial Index (ABI)
timeFrame: At 6 and 12 months post-procedure
measure: Rutherford Classificaiton
timeFrame: At 30 days, 6 months, and 1 year post-procedure
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Advanced Cardiac and Vascular Centers
state: Michigan
city: Saint Clair Shores
country: United States
facility: Eastlake Cardiovascular PC
state: Michigan
Study officials:
affiliation: Avinger, Inc.
name: Jaafer Golzar, MD
role: STUDY_CHAIR
References:
citation: Khalili H, Jeon-Slaughter H, Armstrong EJ, Baskar A, Tejani I, Shammas NW, Prasad A, Abu-Fadel M, Brilakis ES, Banerjee S. Atherectomy in below-the-knee endovascular interventions: One-year outcomes from the XLPAD registry. Catheter Cardiovasc Interv. 2019 Feb 15;93(3):488-493. doi: 10.1002/ccd.27897. Epub 2018 Nov 30.
citation: Schwindt AG, Bennett JG Jr, Crowder WH, Dohad S, Janzer SF, George JC, Tedder B, Davis TP, Cawich IM, Gammon RS, Muck PE, Pigott JP, Dishmon DA, Lopez LA, Golzar JA, Chamberlin JR, Moulton MJ, Zakir RM, Kaki AK, Fishbein GJ, McDaniel HB, Hezi-Yamit A, Simpson JB, Desai A. Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study. J Endovasc Ther. 2017 Jun;24(3):355-366. doi: 10.1177/1526602817701720. Epub 2017 Apr 10.