Accessing Peripheral Occluded LesiOns II (APOLO-II)

Study Overview
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Brief Summary
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The current study is a prospective, single-arm, non-randomized, multi-center study to evaluate the outcome of the ENABLER-P Catheter System for crossing chronic total occlusions during endovascular intervention for femoral-popliteal occlusive disease.

Official Title
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Accessing Peripheral Occluded LesiOns II (APOLO-II)

Conditions
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Femoropopliteal Occlusive Disease

Intervention / Treatment
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* Device: ENABLER-P Catheter System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documentation from a previous attempt OR a concurrent reasonable attempt (at least 5 minutes) during this procedure, demonstrating resistance to conventional guidewire crossing; Patient must have objective evidence of lower extremity ischemia; Totally occlusive lesion in a native femoropopliteal artery classified angiographically as absolute (100% occlusion with no flow), where no antegrade filling beyond the occlusion is visible; Target occlusion length is >1cm and ≤ 30 cm; Patient's reference vessel diameter is ≥ 4.0 mm and ≤6.0 mm (by visual angiographic estimation) Patient must be an acceptable candidate for PTA, peripheral artery bypass surgery or peripheral artery stent implantation; Female patients of child bearing potential must have a negative pregnancy test within 48 hours prior to the study procedure; Patient must have been informed of the nature of the study, agree to its provisions, and provide written informed consent; Patient is ≥ 21 years of age. Exclusion Criteria: Patient has hypersensitivity or contraindication to aspirin, heparin, Plavix or radiographic contrast agents which cannot be adequately pre-medicated; The patient requires immediate treatment in more than one occluded vessel, in any combination of grafts or native vessels; Patient has planned femoropopliteal intervention scheduled within 30 days after index procedure; The patient is currently participating in another investigational drug or device trial that may conflict with study data collection and has not completed the entire follow-up period; Patient has no collateral flow distal to the occlusion; Patient's target occlusion has a dissection that occurred within the past 30 days caused by a guidewire attempt; Patient has a history of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency; Patient suffered recent (within the past 6 months) significant gastrointestinal (GI) bleeding; Patient's target lesion or the vessel proximal to the target lesion reveals significant ectasia, dissection, aneurysm or thrombus; Patient has other medical illnesses (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with life-expectancy less than 1 year.

Ages Eligible for Study
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Minimum Age: 21 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: Intervention<br>Intervention | Device: ENABLER-P Catheter System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary safety endpoint of this study is to evaluate in hospital and 30 day major adverse events (MAEs), clinically significant perforations, clinically significant embolization and/or Grade C or greater dissections. |  | 30 days (+/-7 days) | 
| Advancement of the ENABLER-P supported guidewire into or through the CTO in native femoropopliteal artery and subsequent achievement of distal vessel guidewire position with any conventional guidewire. |  | 30 days (+/-7 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Total Occlusion CTO