NCT04776434

SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 723 (actual)
• Sponsor: M.A. Med Alliance S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2021-02-08
• Primary completion: 2024-11-10
• Completion: 2028-12-31
• First posted: 2021-03-01
• Last updated: 2025-09-23

Locations

27 sites across 8 countries: Argentina, Germany, Greece, Netherlands, Singapore, Slovakia, Switzerland, United Kingdom