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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 range

18 Years

Sex

ALL

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: 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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