Follow-up Study in French Practice to Evaluate Improvements in Walking and Pain Relief in Patients Treated With Endovascular Treatment of de Novo Lesions of the Femoropopliteal Artery Above the Knee With LUTONIX®035 or RANGER TM Active Ballon (EQUATEUR)

November 20, 2023 updated by: Centre Hospitalier Universitaire Dijon

Follow-up Study in French Practice to Evaluate the Improvement of Gait and Pain Relief in Patients Treated With Endovascular Endovascular Treatment of de Novo Lesions of the Femoropopliteal Artery Above the Knee With LUTONIX®035 or RANGER TM Active Ballon

This study is part of the subordination for the renewal of the registration of the LUTONIXR035 or RANGERTM drug coated balloon catheter by the CNEDiMTS following the transmission of the results of a French study on quality of life (evaluation of pain relief and walking evaluation criteria) for patients treated for de novo lesions of the femoropopliteal artery above the knee by endovascular treatment with LUTONIXR035 or RANGERTM drug-coated balloon catheters.

In accordance with the HAS practical guide on the approval of medical devices in France (November 2017), the protocol for this study was submitted in advance to the HAS and its suggestions were taken into account when drafting the objectives relative to the population to be included.

A second exhaustive study will be conducted in parallel using SNDS data to complete the CNEDiMTS application in order to evaluate, in the context of this registration renewal, the interest of the technique by documenting limb preservation, overall survival, the rate of re-interventions and the number of stents implanted.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patient having given express oral consent
  • patient to be treated by endovascular procedure with a LUTONIXR035 or RANGER TM drug coated balloon catheter according to the recommendations of the ANSM dated 13/05/2019 1 and possible updates of these recommendations.

Exclusion Criteria:

  • pregnant or likely to be pregnant (a pregnancy test may be carried out if necessary according to the centre's practice)
  • adult unable to express consent
  • patient whose follow-up is considered impossible by the investigator (comprehension problem, planned move, ...)

Per-intervention exclusion criteria

  • patient considered to have failed endovascular treatment (presence of residual stenosis of more than 30% after surgery despite the possible use of a stent.
  • Patient operated on but for whom the balloon was not used during the procedure
  • Patient operated but for whom another balloon than those under study was finally used during the operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LUTONIX(R)035 drug-coated balloon catheter
6-minute walk test
WIQ functional questionnaire
quality of life questionnaires (EQ5D5L and SF-36)
Experimental: RANGER TM drug-coated balloon catheter
6-minute walk test
WIQ functional questionnaire
quality of life questionnaires (EQ5D5L and SF-36)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
average score of the WIQ specific self-questionnaire
Time Frame: at inclusion
at inclusion
average score of the WIQ specific self-questionnaire
Time Frame: and at 12 months after surgery
progression of the functional limitations for walking evaluated by the average score of the WIQ specific self-questionnaire 12 months after surgery
and at 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2020

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STEINMETZ BOSTON BARD 2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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