Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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

Treatment groups

180 Participants
are divided into 2 treatment groups