Clinical trial NCT05612438: RADIX 2 RENAL STENT Post-Market Retrospective Study
Official title: RADIX 2 RENAL ARTERY STENT Evaluation of Safety and Performance in Everyday Clinical Practice: Post-Market Retrospective Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Artery Stenosis
Renal Failure
Lead sponsor: CID S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: Meditrial Europe Ltd.
First posted: 2022-11-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected with occlusive lesions of the native renal artery disease treated with the study stent, these patients are generally affected by cardiovascular comorbidities with a high incidence of mortality or in the terminal phase of the disease or in advanced age and in serious health conditions

Brief 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.

Detailed description: The objective of this post-market study is collect retrospective clinical data on the implantable medical device Radix 2 stent in an unselected population treated in the current clinical practice. Data will be collected via medical chart review in anonymous form.

Radix2 is a bare metal balloon expandable stent with a progressive multicellular design for treatment of renal artery stenosis. The stent is stent coated with i-Carbofilm™ to accelerate the rate of endothelization and strut coverage.

The product is CE marked and commercially available since July 2010. Additional technical information on RADIX2 is available online: http://www.alvimedica.com/Product/15/bms-b-e-radix2

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

Primary outcomes:
measure: Major renal events
timeFrame: 30 days
Secondary outcomes:
measure: Acute device success
timeFrame: 24 hours
measure: Technical success
timeFrame: 24 hours
measure: In Stent Restenosis
timeFrame: 12 months
measure: Arterial Blood Pressure
timeFrame: 12 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
Study officials:
References:
citation: Zeller T, Rastan A, Kliem M, Schwarzwalder U, Frank U, Burgelin K, Schwarz T, Amantea P, Muller C, Neumann FJ. Impact of carbon coating on the restenosis rate after stenting of atherosclerotic renal artery stenosis. J Endovasc Ther. 2005 Oct;12(5):605-11. doi: 10.1583/05-1599MR.1.