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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paclitaxel delivery in femoropopliteal artery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nellie DELLA SCHIAVA, MD | department of vascular surgery, Edouard Herriot Hospital, LYON | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| department of vascular surgery, Edouard Herriot Hospital, 5 Place d'Arsonval | Lyon | 69003 | France |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| 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 |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |