Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2023-03-03
2023-08-30
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion 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
18 Years
ALL
No
Sponsors
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Meditrial Europe Ltd.
INDUSTRY
CID S.p.A.
INDUSTRY
Responsible Party
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Locations
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Centro Cardiologico Monzino
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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Manufacturer website
Clinical Research Organization
Other Identifiers
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P12204
Identifier Type: -
Identifier Source: org_study_id
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