First in Human Study of Winsor Laser Catheter: A Prospective Registry to Evaluate The Safety and Performance of the Winsor Laser Catheter in the Treatment of In-Stent Restenosis

Study Overview
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Brief Summary
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The study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)

Official Title
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First in Human Study of Winsor Laser Catheter

Conditions
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Femoropopliteal In-Stent Restenosis

Intervention / Treatment
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* Device: Winsor Laser Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age ≥ 18 years. Rutherford Category 2-4. Subject has been informed of the nature of the study, agrees to participate and has signed an Ethics Committee approved informed consent form. Documentation of significant ISR defined as >50% stenosis and >5 cm in length determined by diagnostic angiogram or duplex ultrasound. A previously deployed bare nitinol stent(s) in the femoropopliteal segment extending from the ostium of the SFA to 1 cm above the tibioperoneal trunk. A guidewire has successfully traversed the target treatment segment, or is able to cross using standard support catheter crossing techniques, is angiographically documented to be within true lumen and not placed through stent struts. Guidewire access may obtained via contralateral, ipsilateral or retrograde approach. If a retrograde guidewire approach is used to cross the target lesion, guidewire exchange and an antegrade approach is required prior to treatment with the Winsor Laser Catheter. One or more patent tibial vessel(s) defined as <50% stenosis thoughout the segment with outflow to the foot. Successful treatment of any inflow lesion(s) defined as final residual stenosis <30%. Exclusion Criteria: Patient is pregnant. Has known uncontrollable hypercoagulable condition, or refuses blood transfusion. Any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention. Crossing devices other than guidewire support catheters. Type 4 or 5 stent fracture as assessed by angiography. Target lesion is located within a covered stent. Acute limb ischemia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Winsor Laser Catheter<br> | Device: Winsor Laser Catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | Freedom from Major Adverse Events (MAE) through hospital discharge: All-cause peri-procedural death Target limb amputation (above or below the ankle) Target limb re-intervention Target limb-related death | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Procedural success defined as the percent of target lesions that achieve ≤30% residual stenosis at the completion of the procedure (laser atherectomy and any adjunctive treatment) as determined by an independent angiographic core lab. | During Interventional Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ISR, Laser, SFA, PAD