RADIX 2 RENAL STENT Post-Market Retrospective Study

Renal Failure Clinical Trial

— RADIX 2  

Official title:

RADIX 2 RENAL ARTERY STENT Evaluation of Safety and Performance in Everyday Clinical Practice: Post-Market Retrospective Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05612438
• Other study ID #: P12204
• Status: Not yet recruiting
• Start date: March 3, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: November 2022
• Source: CID S.p.A.
• Contact: Franco Vallana, MD
• Phone: +39 0161 18261
• Email: franco.vallana[@]alvimedica.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Artery Obstruction
• Renal Artery Stenosis
• Renal Failure

Intervention

Device:
• RADIX 2 Stent
RADIX 2 stent implantation for the treatment of occlusive lesions of the native renal arteries; or in the case of inadequate results (residual stenosis > 30%) or dissection of the vessel wall following PTRA procedure with or without stenting.

Locations

Country	Name	City	State
Italy	Centro Cardiologico Monzino	Milano

Sponsors (2)

Lead Sponsor	Collaborator
CID S.p.A.	Meditrial Europe Ltd.

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Zeller T, Rastan A, Kliem M, Schwarzwälder U, Frank U, Bürgelin K, Schwarz T, Amantea P, Müller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major renal events	Major renal events at 30 days - composite of: death from renal causes, related to study device or procedure; embolic events related to study device or procedure, resulting in kidney damage; acute kidney injury Stage 3 (AKIN criteria); ipsilateral nephrectomy, related to the study device or procedure.	30 days
Secondary	Acute device success	Acute Device Success, defined as the successful delivery of the assigned device(s) to the designated target location	24 hours
Secondary	Technical success	Technical Success, defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30%	24 hours
Secondary	In Stent Restenosis	Restenosis of Radix2 stent, requiring repeat revascularization	12 months
Secondary	Arterial Blood Pressure	Systolic and diastolic arterial blood pressure changes during follow-up	12 months

External Links

•   Clinical Research Organization
•   Manufacturer website