NCT04793581

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

Assessment of the Utility of the Pantheris SV System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Avinger, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Atherectomy	Directional atherectomy of lesions below the knee.

Timeline

• Start date: 2021-01-29
• Primary completion: 2025-02-01
• Completion: 2025-08-01
• First posted: 2021-03-11
• Last updated: 2024-07-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study