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OpenTrials
Completed

NCT Number: NCT02835586

STREAMER : STent Restenosis And MEdicaments Release

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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Key information

Conditions

Critical Ischemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

department of vascular surgery, Edouard Herriot Hospital, 5 Place d'Arsonval

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Percentage of patients with femoropopliteal artery restenosis

    Time frame: 12 months

    defined as restenosis > 50 % with a velocity pick > 2,5 on duplex ultrasound

Secondary outcomes

  1. Occurence of adverse events due to paclitaxel

    Time frame: From1 day to 12 months

    biological adverse events (thrombopenia, neutropenia)

  2. Number of patients with target lesion revascularization

    Time frame: 12 months

    number of subjects who need a new revascularization on the same artery (femoropopliteal)

  3. Occurence of amputation free-survival

    Time frame: 12 months

  4. cumulated rate of morbi-mortality (TCMM)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: STREAMER

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 18, 2016
Registry last updated
Jul 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.