CompletedPhase 3

STREAMER : STent Restenosis And MEdicaments Release

France15 participantsStarted 2013-05

Plain-language summary

It is a pilot study to evaluate the feasibility and the efficiency of local delivery of paclitaxel after stenting of long femoropopliteal arterial lesions TASC C and D before the realization of a large randomized multicentric study. Patients concerned are in critical ischemia.

Who can participate

Age range18 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: * patients with critical ischemia of a lower limb with ankle pressure \< 50 mmHg * lesions TASC C and D of the superficial femoral or popliteal artery Exclusion Criteria: * patient allergic to paclitaxel * patient with a cancer, a neutropenia, with immunosuppressor medicament or chemotherapy * patient with contraindication to take 2 anti-aggregants platelets

What they're measuring

Percentage of patients with femoropopliteal artery restenosis

Timeframe: 12 months

Trial details

NCT IDNCT02835586

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-11

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