Renal Artery Stenosis, Renal Failure
Conditions
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.
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
Interventions
DEVICERADIX 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.
Sponsors
Meditrial Europe Ltd.
CID S.p.A.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major renal events | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute device success | 24 hours | Acute Device Success, defined as the successful delivery of the assigned device(s) to the designated target location |
| Technical success | 24 hours | Technical Success, defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30% |
| In Stent Restenosis | 12 months | Restenosis of Radix2 stent, requiring repeat revascularization |
| Arterial Blood Pressure | 12 months | Systolic and diastolic arterial blood pressure changes during follow-up |
Countries
Italy
Contacts
Primary ContactFranco Vallana, MD
Backup ContactMonica Tocchi, MD
Outcome results
None listed