Femoropopliteal Occlusive Disease
Conditions
Keywords
Chronic Total Occlusion CTO
Brief summary
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.
Interventions
DEVICEENABLER-P Catheter System
Sponsors
EndoCross Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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) |
Outcome results
None listed