Back to resultsSTREAMER : STent Restenosis And MEdicaments Release (STREAMER)
Primary Purpose
Critical Ischemia
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Critical Ischemia focused on measuring paclitaxel, critical ischemia, restenosis, femoropopliteal artery lesions TASC C and D
Eligibility Criteria
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
Sites / Locations
- department of vascular surgery, Edouard Herriot Hospital, 5 Place d'Arsonval
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
paclitaxel delivery in femoropopliteal artery
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients with femoropopliteal artery restenosis
defined as restenosis > 50 % with a velocity pick > 2,5 on duplex ultrasound
Secondary Outcome Measures
Occurence of adverse events due to paclitaxel
biological adverse events (thrombopenia, neutropenia)
Number of patients with target lesion revascularization
number of subjects who need a new revascularization on the same artery (femoropopliteal)
Occurence of amputation free-survival
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02835586
Brief Title
STREAMER : STent Restenosis And MEdicaments Release
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Ischemia
Keywords
paclitaxel, critical ischemia, restenosis, femoropopliteal artery lesions TASC C and D
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
paclitaxel delivery in femoropopliteal artery
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
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 Outcome Measure Information:
Title
Percentage of patients with femoropopliteal artery restenosis
Description
defined as restenosis > 50 % with a velocity pick > 2,5 on duplex ultrasound
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Occurence of adverse events due to paclitaxel
Description
biological adverse events (thrombopenia, neutropenia)
Time Frame
From1 day to 12 months
Title
Number of patients with target lesion revascularization
Description
number of subjects who need a new revascularization on the same artery (femoropopliteal)
Time Frame
12 months
Title
Occurence of amputation free-survival
Time Frame
12 months
Title
cumulated rate of morbi-mortality (TCMM)
Description
myocardial infarction, death, vascular ischemic accident, cardiac angina, major amputation, new hospitalization or new surgery for hematoma, thrombosis or false aneurysm
Time Frame
up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nellie DELLA SCHIAVA, MD
Organizational Affiliation
department of vascular surgery, Edouard Herriot Hospital, LYON
Official's Role
Principal Investigator
Facility Information:
Facility Name
department of vascular surgery, Edouard Herriot Hospital, 5 Place d'Arsonval
City
Lyon
ZIP/Postal Code
69003
Country
France
12. IPD Sharing Statement
Learn more about this trial
STREAMER : STent Restenosis And MEdicaments Release
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