CompletedNot Applicable

Essential Pro PMCF Study ( rEPIC04E )

Spain161 participantsStarted 2022-09-26

Plain-language summary

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Essential Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Essential Pro.

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: * Patient treated with Essential Pro according to routine hospital practice and following instructions for use * Informed consent signed Exclusion Criteria: • Not meet inclusion criteria

What they're measuring

Safety Endpoint. Freedom from Target Lesion Failure

Timeframe: 12 months

Trial details

NCT IDNCT05292092

SponsorFundación EPIC

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-29

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