Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries (NCT03791970) | Clinical Trial Compass
RecruitingNot Applicable
Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries
China180 participantsStarted 2019-01-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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;
✓. Patients must be able to be treated with DCB or POBA for post-dilation;
✓. Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be treated with available device size matrix;
✓. At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with stents placement).
✓. No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
Exclusion criteria
✕. 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);
What they're measuring
1
Primary patency rate
Timeframe: 12 months post-procedure
Trial details
NCT IDNCT03791970
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
✕. 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;
✕. Intended treatment of outflow disease during the index procedure;
✕. Intended use of laser, atherectomy or cryoplasty during index procedure;
✕. Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;