Chronic Total Occlusion Crossing With the Wildcat Catheter

Study Overview
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Brief Summary
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This is a prospective, multi-center, non-randomized study of the Wildcat Catheter to cross a single femoropopliteal chronic total occlusion (CTO). Safety and efficacy will be evaluated during the index procedure through 30-day follow-up.

Detailed Description
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Patients with a CTO, defined as 99% to 100% stenosis of a peripheral artery, will be approached for enrollment in the study. Following providing informed consent, the CTO will be addressed by the Wildcat catheter, which will provide a route for the advancement of guidewires and other tools beyond the CTO. Data will be collected to assess the safety efficacy of use of the device during the procedure and up to 30 days post-procedure.

Official Title
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A Non-randomized Study of the Avinger Wildcat Used to Cross Femoropopliteal CTOs

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is willing and able to provide informed consent. Patient is willing and able to comply with the study protocol. Patient is > 18 years old. Patient has peripheral arterial disease requiring revascularization as evidenced by contrast, CT or MR angiography. Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate. Target femoropopliteal vessel is ≥ 3.0 mm in diameter. Patient has Rutherford Classification of 2-5. Exclusion Criteria: Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated. Patient has a known sensitivity or allergy to anti-platelet medications. Patient is pregnant or lactating. Patient has a co-existing disease or medical condition contraindicating percutaneous intervention. Target vessel is severely calcified as evidenced by angiography. Target lesion is in a bypass graft. Target lesion is in a stent (i.e., in-stent restenosis). Patient has had a procedure on the target limb within 7 days. Patient has had a procedure on the target limb within the past 30 days and is unstable. Patient is simultaneously participating in an investigational device or drug study. Patient has a planned surgical or interventional procedure within 30 days after the study procedure.

Ages Eligible for Study
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Minimum Age: 19 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: Treatment<br>The Wildcat catheter is a CTO crossing catheter. Subjects will be subjected to crossing with this device. | Device: Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer<br>* A Non-Randomized Study of the Avinger Wildcat™ used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries<br>* Other names: CONNECT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events | The primary safety endpoint of the CONNECT Study was defined as absence of in-hospital or 30-days Major Adverse Events (MAEs), no evidence of clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Wildcat CTO crossing confirmed by angiography. | Index through 30-Day Follow-Up | 
| CTO Crossing Success Using the Wildcat | Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography. | Index through 30-Day Follow-Up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Total Occlusions, Superficial Femoral Artery, Popliteal Artery