STREAMER : Stent Restenosis and Medicaments Release : Does Local Delivery of Paclitaxel be Safe and Efficient in Stenting of TransAtlantic InterSociety Consensus (TASC) Class C and D Femoropopliteal Artery Lesions

Hospices Civils de Lyon1 site in 1 country15 target enrollmentMay 2013

ConditionsCritical Ischemia

InterventionsPaclitaxel

DrugsPaclitaxel

Overview

Phase: Phase 3
Intervention: Paclitaxel
Conditions: Critical Ischemia
Sponsor: Hospices Civils de Lyon
Enrollment: 15
Locations: 1
Primary Endpoint: Percentage of patients with femoropopliteal artery restenosis
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

November 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

Eligibility Criteria

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