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STREAMER : STent Restenosis And MEdicaments Release

NCT02835586 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-07-18

No results posted yet for this study

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.

Conditions

  • Critical Ischemia

Interventions

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Nellie DELLA SCHIAVA, MD · department of vascular surgery, Edouard Herriot Hospital, LYON

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02835586 on ClinicalTrials.gov