STREAMER : STent Restenosis And MEdicaments Release

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Critical Ischemia

Treatments: Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT02835586

2011-701

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

paclitaxel delivery in femoropopliteal artery

Experimental group

Treatment:

Drug: Paclitaxel