Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04776434
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-30
First Post:
2021-02-10
Brief Title:
SUCCESS SelUtion Safety effiCaCy hEalth economicS and promS PTA Study
Sponsor:
MA Med Alliance SA
Organization:
MA Med Alliance SA
Study Overview
Official Title:
SUCCESS SelUtion Safety effiCaCy hEalth economicS and promS PTA Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUCCESS PTA
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 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 ie non-cardiovascular vascular lesion
Data analysis will be stratified by lesion location
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 ie non-cardiovascular vascular lesion
Data analysis will be stratified by lesion location
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None