RADIX 2 RENAL STENT Post-Market Retrospective Study

CID S.p.A.

Status: Not yet enrolling

Conditions: Renal Failure; Renal Artery Stenosis

Treatments: Device: RADIX 2 Stent

Study type: Observational

Funder types: Industry

Identifiers

NCT05612438

P12204

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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