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

M.A. Med Alliance

Status: Active, not recruiting

Conditions: Peripheral Artery Disease

Treatments: Device: SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04776434

S2020-01

Details and patient eligibility

About

Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).

Full 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.

Enrollment: 723 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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723 participants in 1 patient group

SELUTION SLR™ DEB

Experimental group

Description:

Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter.

Treatment:

Device: SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)