STREAMER : STent Restenosis And MEdicaments Release

Phase 3

Completed

• Conditions: Critical Ischemia
• Interventions: Drug: Paclitaxel

• Registration Number: NCT02835586
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-07
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-13
• Last Update Submitted: 2016-07-13
• Study First Posted: 2016-07-18
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
paclitaxel delivery in femoropopliteal artery	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with femoropopliteal artery restenosis	12 months	defined as restenosis \> 50 % with a velocity pick \> 2,5 on duplex ultrasound

Secondary Outcome Measures

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

Trial Locations

Locations (1)

department of vascular surgery, Edouard Herriot Hospital, 5 Place d'Arsonval; 🇫🇷 Lyon, France