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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

NCT04798352 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 293

Last updated 2026-02-12

No results posted yet for this study

Summary

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.

Conditions

  • Drug-coated Balloon Catheter

Interventions

OTHER

6-minute walk test

6-minute walk test

OTHER

WIQ functional questionnaire

WIQ functional questionnaire

OTHER

quality of life questionnaires (EQ5D5L and SF-36)

quality of life questionnaires (EQ5D5L and SF-36)

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-04
Primary Completion
2026-01-08
Completion
2026-01-08

Countries

  • France

Study Locations

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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 NCT04798352 on ClinicalTrials.gov