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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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
department of vascular surgery, Edouard Herriot Hospital, 5 Place d'Arsonval
Lyon, France
Percentage of patients with femoropopliteal artery restenosis
defined as restenosis \> 50 % with a velocity pick \> 2,5 on duplex ultrasound
Time frame: 12 months
Occurence of adverse events due to paclitaxel
biological adverse events (thrombopenia, neutropenia)
Time frame: 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)
Time frame: 12 months
Occurence of amputation free-survival
Time frame: 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
Time frame: up to 30 days
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