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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Drug-coated Balloon Catheter

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |