Assessment of the Utility of the Pantheris Small Vessel (SV) System

Avinger

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Device: Atherectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04793581

IMAGE BTK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Single Arm

Other group

Description:

Single-arm study

Treatment:

Device: Atherectomy