- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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 (EQUATEUR)
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
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dijon, France, 21000
- Recruiting
- CHU Dijon Bourgogne
-
Contact:
- Eric STEINMETZ
- Phone Number: +33 03 80 29 33 52
- Email: eric.steinmetz@chu-dijon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LUTONIX(R)035 drug-coated balloon catheter
|
6-minute walk test
WIQ functional questionnaire
quality of life questionnaires (EQ5D5L and SF-36)
|
Experimental: RANGER TM drug-coated balloon catheter
|
6-minute walk test
WIQ functional questionnaire
quality of life questionnaires (EQ5D5L and SF-36)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
average score of the WIQ specific self-questionnaire
Time Frame: at inclusion
|
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
|
and at 12 months after surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STEINMETZ BOSTON BARD 2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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