Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
15 participants
INTERVENTIONAL
2013-05-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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paclitaxel delivery in femoropopliteal artery
Paclitaxel
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
Interventions
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Paclitaxel
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
Eligibility Criteria
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Inclusion Criteria
* lesions TASC C and D of the superficial femoral or popliteal artery
Exclusion Criteria
* patient with a cancer, a neutropenia, with immunosuppressor medicament or chemotherapy
* patient with contraindication to take 2 anti-aggregants platelets
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Nellie DELLA SCHIAVA, MD
Role: PRINCIPAL_INVESTIGATOR
department of vascular surgery, Edouard Herriot Hospital, LYON
Locations
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department of vascular surgery, Edouard Herriot Hospital, 5 Place d'Arsonval
Lyon, , France
Countries
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Other Identifiers
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2011-701
Identifier Type: -
Identifier Source: org_study_id
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