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

Not Applicable

Recruiting

• Conditions: Drug-coated Balloon Catheter
• Interventions: Other: 6-minute walk test; Other: WIQ functional questionnaire; Other: quality of life questionnaires (EQ5D5L and SF-36)

• Registration Number: NCT04798352
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-04
• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
average score of the WIQ specific self-questionnaire	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

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France