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)
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| ClinicalTrials.gov Identifier: NCT04798352 |
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Recruitment Status :
Recruiting
First Posted : March 15, 2021
Last Update Posted : March 2, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Drug-coated Balloon Catheter | Other: 6-minute walk test Other: WIQ functional questionnaire Other: quality of life questionnaires (EQ5D5L and SF-36) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| 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 |
| Actual Study Start Date : | December 4, 2020 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | December 2024 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: LUTONIX(R)035 drug-coated balloon catheter |
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) |
| Experimental: RANGER TM drug-coated balloon catheter |
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) |
- average score of the WIQ specific self-questionnaire [ Time Frame: at inclusion ]
- average score of the WIQ specific self-questionnaire [ Time Frame: 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
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 opéré mais pour lequel le ballon n'a finalement pas été utilisé au cours de l'intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04798352
| France | |
| Chu Dijon Bourgogne | Recruiting |
| Dijon, France, 21000 | |
| Contact: Eric STEINMETZ 03 80 29 33 52 ext +33 eric.steinmetz@chu-dijon.fr | |
| Responsible Party: | Centre Hospitalier Universitaire Dijon |
| ClinicalTrials.gov Identifier: | NCT04798352 |
| Other Study ID Numbers: |
STEINMETZ BOSTON BARD 2019 |
| First Posted: | March 15, 2021 Key Record Dates |
| Last Update Posted: | March 2, 2022 |
| Last Verified: | February 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |