STREAMER : STent Restenosis And MEdicaments Release (STREAMER)

July 13, 2016 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • department of vascular surgery, Edouard Herriot Hospital, 5 Place d'Arsonval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: paclitaxel delivery in femoropopliteal artery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with femoropopliteal artery restenosis
Time Frame: 12 months
defined as restenosis > 50 % with a velocity pick > 2,5 on duplex ultrasound
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of adverse events due to paclitaxel
Time Frame: From1 day to 12 months
biological adverse events (thrombopenia, neutropenia)
From1 day to 12 months
Number of patients with target lesion revascularization
Time Frame: 12 months
number of subjects who need a new revascularization on the same artery (femoropopliteal)
12 months
Occurence of amputation free-survival
Time Frame: 12 months
12 months
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
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Nellie DELLA SCHIAVA, MD, department of vascular surgery, Edouard Herriot Hospital, LYON

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (ESTIMATE)

July 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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