Radiofrequency for the Treatment of Peripheral Vascular Occlusive Disease of the Lower Extremities

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of the Minnow Medical GRST Peripheral Catheter System in the treatment of new lesions in the superficial femoral artery or the popliteal artery.

Official Title
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Minnow Medical GRST Peripheral Catheter System First-in-Man Study Radiofrequency for the Treatment of Peripheral Vascular Occlusive Disease of the Lower Extremities

Conditions
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Peripheral Vascular Disease

Intervention / Treatment
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* Device: GRST Peripheral Catheter System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥18 years of age Patient is Rutherford category 2-4 De novo lesion in the SFA or popliteal artery with a diameter stenosis ≥50% Target lesion is a de novo occlusion that can be successfully pre-dilated resulting in a lesion of <99% Target lesion stenosis has a length of ≤100 mm based on visual assessment Target vessel reference diameter is ≥3.0 mm and ≤7.0 mm based on visual assessment Angiographic evidence of distal runoff defined as minimum one (1) patent tibial artery with a straight flow to the foot Patient is willing and able to provide written informed consent prior to any study specific procedure Patient is willing and able to comply with specified follow-up evaluations at the specified times Exclusion Criteria: Any prior intervention in the intended target lesion including 10 mm proximal or distal from the intended treatment area Evidence of thrombus in the target vessel Prior ipsilateral or contralateral lower limb arterial bypass Treatment of ipsilateral lesions during the index procedure or planned treatment after the index procedure Target lesion is severely calcified Any known allergies and / or intolerances to the following: ASA, Clopidogrel, Heparin, contrast agents (that cannot be adequately pre-medicated). Any planned surgery within 30 days of the study procedure. Renal failure (serum creatinine > 2.0 mg/dL) Female with childbearing potential without a negative pregnancy test Patient has had an organ transplant Patient is currently participating in an investigational drug or device study which has not reached the primary endpoint yet or which clinically interferes with the endpoints of this study In the investigator's opinion, the patient has a severe co-morbid condition(s) that could limit the ability to participate in the study

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>GRST Peripheral Catheter System | Device: GRST Peripheral Catheter System<br>* Treatment to dilate stenoses and reduce plaque in treated vessels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse clinical events rate |  | Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary restenosis |  | 30 days, 3 months, 6 months | 
| Target lesion revascularization |  | 30 days, 3 months, 6 months | 
| Amputation rate |  | 30 days, 3 months, 6 months | 
| Technical success |  | Treatment | 
| Serious adverse events rate, including major adverse clinical events |  | 30 days, 3 months, 6 months |