Status:
ACTIVE_NOT_RECRUITING
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Lead Sponsor:
M.A. Med Alliance S.A.
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).
Detailed Description
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB). This study will capture data f...
Eligibility Criteria
Inclusion
- Subject age is ≥ 18 years
- Subject is able and willing to provide informed consent
- Subject is suitable for treatment with a MedAlliance SELUTION SLR DEB according to the current Instruction for use.
Exclusion
- In the opinion of the treating investigator the subject has a life expectancy of less than 12 months
- In the opinion of the treating investigator the subject is unlikely to comply with the study follow-up regime
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2028
Estimated Enrollment :
723 Patients enrolled
Trial Details
Trial ID
NCT04776434
Start Date
February 8 2021
End Date
December 31 2028
Last Update
September 23 2025
Active Locations (27)
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1
Hospital Italiano La Plata
La Plata, Argentina
2
Klinikum Hochsauerland
Arnsberg, Germany
3
Universitätsklinikum Freiburg
Bad Krozingen, Germany
4
Krankenhaus Buchholz
Buchholz, Germany