Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Drug-coated Balloon Catheter
Eligibility:
All Genders
Phase:
NA
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 F...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04798352
Start Date
December 4 2020
End Date
January 1 2026
Last Update
June 17 2025
Active Locations (1)
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1
Chu Dijon Bourgogne
Dijon, France, 21000