SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Peripheral Artery Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 from the use of the SELUTION SLR according to its approved labelling. Each indication for use will hav...
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 from the use of the SELUTION SLR according to its approved labelling. Each indication for use will have a specific data sets in addition to generic data sets that are common across all indications. Patients will be followed for 5 years post-procedure to obtain safety and efficacy data. A health economic analysis will be made comparing data between countries within the study and to published data for existing treatment options. Generic and disease specific Patient Reported Outcome Measures (PROMs) will be used to measure the impact of the intervention on the overall health status of patients. Imaging data collection for patients whose standard of care includes imaging follow-up will be captured and analysed. Data will be collected from any subject who receives a CE marked device for treatment of a peripheral (i.e. non-cardiovascular) vascular lesion. Data analysis will be stratified by lesion location.
Tracking Information
- NCT #
- NCT04776434
- Collaborators
- Not Provided
- Investigators
- Not Provided