STREAMER : STent Restenosis And MEdicaments Release

Critical Ischemia Clinical Trial

— STREAMER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835586
• Other study ID #: 2011-701
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2016
• Last updated: July 13, 2016
• Start date: May 2013
• Est. completion date: November 2015

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Ischemia
• Ischemia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	department of vascular surgery, Edouard Herriot Hospital, 5 Place d'Arsonval	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with femoropopliteal artery restenosis	defined as restenosis > 50 % with a velocity pick > 2,5 on duplex ultrasound	12 months	No
Secondary	Occurence of adverse events due to paclitaxel	biological adverse events (thrombopenia, neutropenia)	From1 day to 12 months	No
Secondary	Number of patients with target lesion revascularization	number of subjects who need a new revascularization on the same artery (femoropopliteal)	12 months	No
Secondary	Occurence of amputation free-survival		12 months	No
Secondary	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	No