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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
Time frame: 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.
Time frame: 30 days (+/-7 days)
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