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.
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
50
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.
Centro Cardiologico Monzino
Milan, Italy
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.
Time frame: 30 days
Acute device success
Acute Device Success, defined as the successful delivery of the assigned device(s) to the designated target location
Time frame: 24 hours
Technical success
Technical Success, defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30%
Time frame: 24 hours
In Stent Restenosis
Restenosis of Radix2 stent, requiring repeat revascularization
Time frame: 12 months
Arterial Blood Pressure
Systolic and diastolic arterial blood pressure changes during follow-up
Time frame: 12 months
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