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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of the Utility of the Pantheris SV System

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Atherectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>Single-arm study | Device: Atherectomy<br>* Directional atherectomy of lesions below the knee.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events | freedom from cardiovascular-related events | from procedure to 30 days post-procedure | 
| Technical success | defined as residual stenosis < 50 percent after atherectomy | At 1 day post-procedure | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral artery disease (PAD) below-the-knee atherectomy