STREAMER : STent Restenosis And MEdicaments Release

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Critical Ischemia

Intervention / Treatment
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* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paclitaxel delivery in femoropopliteal artery<br> | Drug: Paclitaxel<br>* Paclitaxel will be administered intra-arterially through an irrigating catheter to treat a diseased segment of superficial femoral artery and/or popliteal artery after stenting. Dosing will be based on the lesion surface area and will be calculated using the following formula : 22/7 x diameter (mm) x length (mm) x 3 µg/mm3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with femoropopliteal artery restenosis | defined as restenosis > 50 % with a velocity pick > 2,5 on duplex ultrasound | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of adverse events due to paclitaxel | biological adverse events (thrombopenia, neutropenia) | From1 day to 12 months | 
| Number of patients with target lesion revascularization | number of subjects who need a new revascularization on the same artery (femoropopliteal) | 12 months | 
| Occurence of amputation free-survival |  | 12 months | 
| cumulated rate of morbi-mortality (TCMM) | myocardial infarction, death, vascular ischemic accident, cardiac angina, major amputation, new hospitalization or new surgery for hematoma, thrombosis or false aneurysm | up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paclitaxel, critical ischemia, restenosis, femoropopliteal artery lesions TASC C and D