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NCT05612438
RADIX 2 RENAL STENT Post-Market Retrospective Study
Conditions: Renal Artery Stenosis, Renal Failure
Sex: All
Ages: 18 Years – N/A
Enrollment: 50
Sponsor: CID S.p.A.
Location: Italy
Summary
The Carbostent™ Radix 2 stent is a CE marked balloon expandable bare metal stent for the treatment of renal artery stenosis.The aim of this post-market retrospective study protocol P12204, is to collect clinical data on patients treated with the RADIX 2 stent in routine clinical practice.In order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with the Radix 2 stent at least 12 months prior to the study start.
Eligibility Criteria
Inclusion Criteria:The study will be conducted in the "real world" population, according to the following criteria.Selection criteria:Patient has been implanted with at least one study stent (Radix2) according to the indications described in the IFU.Study Device Implanted is at least12 months prior to the starting date of the retrospective anonymous data collection.Exclusion Criteria:Patients treated less than 12 months prior to study start
Source: ClinicalTrials.gov (NCT05612438). StuddyBuddy aggregates publicly available trial information.