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 (EQUATEUR)

University Hospital Center (CHU) Dijon Bourgogne

Status

Active, not recruiting

Conditions

Drug-coated Balloon Catheter

Treatments

Other: quality of life questionnaires (EQ5D5L and SF-36)

Other: WIQ functional questionnaire

Other: 6-minute walk test

Study type

Interventional

Funder types

Other

Identifiers

NCT04798352

STEINMETZ BOSTON BARD 2019

Details and patient eligibility

About

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.

Enrollment

270 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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