Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries
A Prospective, Single Center, Case-cohort Study Using the Orchid Drug Coated Balloon for Post-Dilatation of the Stent for Treatment of Long Lesions in Femoropopliteal Arteries
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
180 participants
Jan 1, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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;
- Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to index procedure;
- Lesion location starts ≥1 cm below the common femoral bifurcation and P1 popliteal artery.
Exclusion Criteria12
- 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;
- 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;
- History of stroke within 3 months;
- History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
- Participation in an investigational drug or another investigational device study until this study's primary endpoint is reached or previous enrollment in this study;
- Another medical condition, which, in the opinion of the Investigator, may cause the patient to be noncompliant with the Concern/Information Need/Participation Willingness (CIP) or confound data interpretation;
- Target vessel and/or lesion involves a previously placed stent.
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Interventions
Stents placement for femoropopliteal arterial occlusions following with Orchid 035 DCB Catheter for post-dilation
Stents placement for femoropopliteal arterial occlusions following with POBA for post-dilation
Locations(3)
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NCT03791970