STREAMER : STent Restenosis And MEdicaments Release

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02835586

Acronym

STREAMER

Enrollment

Registered

2016-07-18

Start date

2013-05-31

Completion date

2015-11-30

Last updated

2016-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Ischemia

Keywords

paclitaxel, critical ischemia, restenosis, femoropopliteal artery lesions TASC C and D

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.

Interventions

DRUGPaclitaxel

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Occurence of adverse events due to paclitaxel	From1 day to 12 months	biological adverse events (thrombopenia, neutropenia)
Number of patients with target lesion revascularization	12 months	number of subjects who need a new revascularization on the same artery (femoropopliteal)
Occurence of amputation free-survival	12 months	—
cumulated rate of morbi-mortality (TCMM)	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026