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STREAMER : STent Restenosis And MEdicaments Release

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Civil Hospices of Lyon

Status and phase

Completed
Phase 3

Conditions

Critical Ischemia

Treatments

Drug: Paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT02835586
2011-701

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

paclitaxel delivery in femoropopliteal artery
Experimental group
Treatment:
Drug: Paclitaxel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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