NCT04798352

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 293 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2020-12-04
• Primary completion: 2026-01-08
• Completion: 2026-01-08
• First posted: 2021-03-15
• Last updated: 2026-02-12

Locations

1 site across 1 country: France