AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)

Study Overview
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Brief Summary
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The study is designed to evaluate the safety and efficacy of the AngioSafe Peripheral CTO Crossing System.

Detailed Description
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The purpose of the study is to demonstrate the safety and effectiveness of the AngioSafe Peripheral CTO Crossing System. The system facilitates the crossing of chronic total occlusions (CTOs) in the peripheral arteries of lower limbs. A minimum of 70 subjects will be treated across selected study enters within the U.S. and followed for 30 days.

Official Title
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Safety and Effectiveness Study of the AngioSafe Peripheral CTO Crossing System

Conditions
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Peripheral Artery Occlusion, Peripheral Arterial Disease

Intervention / Treatment
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* Device: AngioSafe Peripheral CTO Crossing System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to comply with protocol requirements and sign informed consent form ≥ 22 years of age Peripheral arterial disease defined by Rutherford Clinical Classification (Category 2-5) Peripheral artery disease in target extremity is confirmed by imaging (catheter angiography, computed tomographic angiography (CTA), and/or magnetic resonance angiography (MRA)) Angiographic Inclusion Criteria: Target lesion in native de novo common femoral artery (CFA), superficial femoral artery (SFA), and/or popliteal artery Vessel diameter(s) for target lesion is ≥ 3.0mm and ≤ 10mm Subject's target lesion is a severely stenosed segment of ≤ 300 mm that involves the CTO(s) Subject's target lesion involves at least one CTO that is 99-100% stenosed Subject has at least one vessel with run-off to the foot Exclusion Criteria: Systemic infection or an infection in extremity of target lesion Target lesion within native vein or synthetic vessel grafts or in stent occlusion Planned intervention in the contralateral limb during the study Planned intervention in the target limb of the inflow vessels during the study Planned intervention of lower extremities after study procedure within 30-day follow-up visit Coagulopathy or bleeding diatheses, thrombocytopenia with platelet count less than 50,000/μl, or INR > 1.7 Antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated Allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated Allergy to nickel, titanium, urethane, nylon, or silicone History of myocardial infarction within 30 days prior to enrollment/consent History of stroke within 30 days prior to enrollment/consent Chronic kidney disease (CKD) of stage 4 or greater based on an Estimated Glomerular Filtration Rate (eGFR) <30ml/Min, unless the subject is on chronic renal replacement therapy Hemoglobin levels <10g/dL verified by a lab test no older than 14 days prior to enrollment, unless the subject has a history of chronic anemia at a stable level, no recent bleeding diathesis or history of blood transfusion in the last six weeks Pregnant or nursing, for females of child-bearing potential (< 50 years of age) Participating in another interventional research study that may interfere with study endpoints Prior major amputation (above ankle) in target extremity Acute limb ischemia (ALI) Prior unsuccessful attempt to cross the target lesion Subject has had a procedure on the target limb or contralateral limb within 7 days Subject has had a procedure on the target limb or contralateral limb within the past 30 days and is unstable

Ages Eligible for Study
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Minimum Age: 22 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: AngioSafe Peripheral CTO Crossing System Procedure<br> | Device: AngioSafe Peripheral CTO Crossing System<br>* The AngioSafe Peripheral CTO Crossing System is intended to facilitate the intraluminal placement of guidewires beyond stenotic lesions, including chronic total occlusions (CTOs) in the peripheral vasculature.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success is defined as Technical Success in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner. |  | 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success of AngioSafe Peripheral CTO Crossing System | Defined as the ability of catheter to facilitate placement of a guidewire into the distal lumen. | Procedure | 
| Procedural Success of AngioSafe Peripheral CTO Crossing System | Defined as Technical Success without a procedural complication within 30 days after the procedure. Procedural complication is defined as the need for open or repeat endovascular surgical repair in the treated limb, or a major bleeding event. | 30 Days | 
| Evaluation of intraluminal CTO crossing facilitated by the Peripheral CTO Crossing System, as assessed by an Intravascular Ultrasound (IVUS). |  | Procedure | 
| The primary endpoint in the subgroup of the degree of calcification (none/focal/mild/moderate, severe). |  | Procedure |