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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    722
  • sponsor
    M.A. Med Alliance S.A.
Updated on 26 April 2022

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).

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.

Details
Condition Peripheral Artery Disease
Treatment SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)
Clinical Study IdentifierNCT04776434
SponsorM.A. Med Alliance S.A.
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

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
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Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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