To compare the efficacy and safety of stent angioplasty with Orchid 035 Drug Coated Dilatation (DCB) and Plain Old Balloon Angioplasty (POBA) for post-dilatation for long (\>10cm) femoropopliteal chronic total occlusion.
Age ≥18 years;
The subject is legally competent and able to understand the information on the study, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF);
Rutherford Category 2-4;
Target de novo lesion(s) or non-stented restenotic lesion(s) has angiographic evidence of long-term occlusion (by visual estimate ≥10cm) and is amenable to treatment with stents placement;
Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
Contraindication to stent or DCB or POBA per current information for use (IFU);
Life expectancy of <1 year;
Inability to take required antiplatelet/anticoagulant medications, or known contraindication (including allergic reaction) or sensitivity to contrast media, nickel, titanium or tantalum that cannot be adequately managed with pre- and post-procedure medication;
Parallel
Orchid 035 DCB Catheter
DeviceStents placement for femoropopliteal arterial occlusions following with Orchid 035 DCB Catheter for post-dilation
POBA Catheter
DeviceStents placement for femoropopliteal arterial occlusions following with POBA for post-dilation
Primary patency rate
Absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.5) at the target lesion and without TLR
Freedom from clinically-driven TLR
TLR defined as a repeated intervention to maintain or re-establish patency within the region of the treated arteries
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