RADIX 2 RENAL STENT Post-Market Retrospective Study (RADIX 2)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Failure; Renal Artery Stenosis
• Intervention / Treatment: Device: RADIX 2 Stent

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

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Franco Vallana, MD; Phone Number: +39 0161 18261; Email: franco.vallana@alvimedica.com

Study Locations

• Italy
  • Milano, Italy
    • Centro Cardiologico Monzino
    • Contact: Pietro Montorsi, MD; Email: invasiva1@cardiologicomonzino.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute device success	Acute Device Success, defined as the successful delivery of the assigned device(s) to the designated target location	24 hours
Technical success	Technical Success, defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30%	24 hours
In Stent Restenosis	Restenosis of Radix2 stent, requiring repeat revascularization	12 months
Arterial Blood Pressure	Systolic and diastolic arterial blood pressure changes during follow-up	12 months

Collaborators and Investigators

• Sponsor: CID S.p.A.
• Collaborators: Meditrial Europe Ltd.

Publications and helpful links

General Publications

• 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.

Helpful Links

• Manufacturer website
• Clinical Research Organization

Study record dates

Study Major Dates

• Study Start (Anticipated): March 3, 2023
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): August 30, 2023

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Renal Artery Obstruction
• Other Study ID Numbers: P12204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No