RADIX 2 RENAL STENT Post-Market Retrospective Study

NCT05612438 | Unknown

• 1 other identifier: P12204
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Artery Stenosis; Renal Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Acute device success

  24 hours

• Technical success

  24 hours

• In Stent Restenosis

  12 months

• Arterial Blood Pressure

  12 months

Interventions

RADIX 2 Stent DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Patients treated less than 12 months prior to study start

Sponsors & Collaborators

• CID S.p.A.: lead
• Meditrial Europe Ltd.: collaborator

Study Sites (1)

Centro Cardiologico Monzino

Milan, Italy

Location

Related Publications (1)

• 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.

  PMID: 16212462 BACKGROUND

Related Links

• Manufacturer website
• Clinical Research Organization

MeSH Terms

Conditions

Renal Artery Obstruction; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Franco Vallana, MD

CONTACT

+39 0161 18261; franco.vallana@alvimedica.com

Monica Tocchi, MD

CONTACT

m.tocchi@meditrial.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 10, 2022
• Study Start: March 3, 2023
• Primary Completion: July 30, 2023
• Study Completion: August 30, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)