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RADIX 2 RENAL STENT Post-Market Retrospective Study

Italy50 participantsStarted 2023-03-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Major renal events

Timeframe: 30 days

Trial details

NCT IDNCT05612438

SponsorCID S.p.A.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-07-30

Contact for this trial

Franco Vallana, MD

+39 0161 18261 franco.vallana@alvimedica.com

View on ClinicalTrials.gov More Renal Artery Stenosis trials