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

Not Applicable

Recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Atherectomy

• Registration Number: NCT04793581
• Lead Sponsor: Avinger, Inc.

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.

Study Timeline

• Study Start: 2021-01-29
• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-02-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Atherectomy	Single-arm study

Primary Outcome Measures

Name	Time	Method
Technical success	At 1 day post-procedure	defined as residual stenosis \< 50 percent after atherectomy
Major Adverse Events	from procedure to 30 days post-procedure	freedom from cardiovascular-related events

Secondary Outcome Measures

Name	Time	Method
Procedure success	At 1 day post-procedure	defined as residual stenosis \< 30 percent post adjunctive therapy
Freedom from target vessel revascularization (TVR)	At 6 and 12 months post-procedure	revascularization needed further
Primary patency	At 6 and 12 months post-procedure	change in peak systolic velocity ratio (PSVR)
Ankle-Brachial Index (ABI)	At 6 and 12 months post-procedure	change since index procedure
Rutherford Classificaiton	At 30 days, 6 months, and 1 year post-procedure	Change since index procedure

Trial Locations

Locations (2)

Advanced Cardiac and Vascular Centers; 🇺🇸 Grand Rapids, Michigan, United States

Eastlake Cardiovascular PC; 🇺🇸 Saint Clair Shores, Michigan, United States