About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Orchid 035 DCB Catheter
- POBA Catheter