Active — Not RecruitingNot Applicable

EucaLimus Post-Market Registry

Czechia, Malaysia, Spain251 participantsStarted 2025-03-14

Plain-language summary

To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the Eucalimus sirolimus eluting PTCA stent when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Eucalimus PTCA stent in routine clinical practice.

Who can participate

Age range18 Years

SexALL

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

Inclusion Criteria: * Consecutive patients intended to be, or treated by EucaLimus as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry. Exclusion Criteria: * Patients are excluded from registration if ANY of the following conditions apply: * High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned * A life expectancy of \<1year * Explicit refusal of participation in the registry

What they're measuring

Adjudicated, device-oriented, Target Lesion Failure (TLF)

Timeframe: 12 months post procedure

Trial details

NCT IDNCT06621524

SponsorOrbusNeich

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-01

View on ClinicalTrials.gov More Coronary Arterioscleroses trials