NCT02835586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

2.5 years

First QC Date

July 11, 2016

Last Update Submit

July 13, 2016

Conditions

Critical Ischemia

Keywords

paclitaxelcritical ischemiarestenosisfemoropopliteal artery lesions TASC C and D

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with femoropopliteal artery restenosis

    defined as restenosis \> 50 % with a velocity pick \> 2,5 on duplex ultrasound

    12 months

Secondary Outcomes (4)

  • Occurence of adverse events due to paclitaxel

    From1 day to 12 months

  • Number of patients with target lesion revascularization

    12 months

  • Occurence of amputation free-survival

    12 months

  • cumulated rate of morbi-mortality (TCMM)

    up to 30 days

Study Arms (1)

paclitaxel delivery in femoropopliteal artery

EXPERIMENTAL
Drug: Paclitaxel

Interventions

PaclitaxelDRUG

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

paclitaxel delivery in femoropopliteal artery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patient allergic to paclitaxel
  • patient with a cancer, a neutropenia, with immunosuppressor medicament or chemotherapy
  • patient with contraindication to take 2 anti-aggregants platelets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

department of vascular surgery, Edouard Herriot Hospital, 5 Place d'Arsonval

Lyon, 69003, France

Location

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Nellie DELLA SCHIAVA, MD

    department of vascular surgery, Edouard Herriot Hospital, LYON

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 18, 2016

Study Start

May 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

July 18, 2016

Record last verified: 2016-07

Locations

FR(1)