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 | Completed

• 1 other identifier: STEINMETZ BOSTON BARD 2019
• Study Type: interventional
• Target: 293
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• average score of the WIQ specific self-questionnaire

  at inclusion

• average score of the WIQ specific self-questionnaire

  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

Study Arms (2)

LUTONIX(R)035 drug-coated balloon catheter

EXPERIMENTAL

Other: 6-minute walk test; Other: WIQ functional questionnaire; Other: quality of life questionnaires (EQ5D5L and SF-36)

RANGER TM drug-coated balloon catheter

EXPERIMENTAL

Other: 6-minute walk test; Other: WIQ functional questionnaire; Other: quality of life questionnaires (EQ5D5L and SF-36)

Interventions

6-minute walk test OTHER

6-minute walk test

LUTONIX(R)035 drug-coated balloon catheter; RANGER TM drug-coated balloon catheter

quality of life questionnaires (EQ5D5L and SF-36) OTHER

quality of life questionnaires (EQ5D5L and SF-36)

LUTONIX(R)035 drug-coated balloon catheter; RANGER TM drug-coated balloon catheter

WIQ functional questionnaire OTHER

WIQ functional questionnaire

LUTONIX(R)035 drug-coated balloon catheter; RANGER TM drug-coated balloon catheter

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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, ...)
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 15, 2021
• Study Start: December 4, 2020
• Primary Completion: January 8, 2026
• Study Completion: January 8, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

FR (1)