CompletedNot Applicable

Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries

Austria, Belgium125 participantsStarted 2013-12

Plain-language summary

To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. ≥ 18 years of age;
✓. Rutherford Clinical Category 2-4;
✓. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF).
✓. Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery (by visual estimate) that is amenable to DCB with or without stenting;
✓. TASC II Class C or D Lesions with intended target lesion treatment segment(s) cumulatively ≥14 cm in length;
✓. de novo lesion(s) or non-stented restenotic lesion(s) \> 90 days from prior angioplasty procedure;
✓. Proximal margin of target lesion(s) starts ≥ 1 cm below the common femoral bifurcation;
✓. Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk;

Exclusion criteria

✕. 1\. Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children;
✕. Patient is contraindicated to use Lutonix Drug Coated Balloon per the current Instructions For Use (IFU)
✕. Life expectancy of \< 1year;
✕. Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in an investigational device or pharmaceutical clinical trial during the follow up period is not allowed.
✕. History of stroke within 3 months;
✕. History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
✕. Prior vascular surgery of the index limb, with the exception of endarterectomy or remote common femoral patch angioplasty, separated by at least 1 cm from the target lesion;
✕. Target lesion involves a previously placed stent

What they're measuring

Overall Medical Safety

Timeframe: 12 Months

Primary Endpoint Efficacy, measured by presence of primary patency of the target lesion. Patency is assessed by a Corelab based on ultrasound images

Timeframe: 12 Months

Trial details

NCT IDNCT02013271

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-05-23

View on ClinicalTrials.gov More Femoral Artery Occlusion trials