Active — Not RecruitingNot Applicable

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

Argentina, Germany723 participantsStarted 2021-02-08

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Clinically Driven Target Lesion Revascularization

Timeframe: 1 year after treatment

Trial details

NCT IDNCT04776434

SponsorM.A. Med Alliance S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-10

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