RADIX 2 RENAL STENT Post-Market Retrospective Study

Study Overview
=================
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

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

Conditions
-----------------
Renal Artery Stenosis, Renal Failure

Intervention / Treatment
-----------------
* Device: RADIX 2 Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 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.|

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 |