RADIX 2 RENAL STENT Post-Market Retrospective Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
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.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centro Cardiologico Monzino | Milano | Italy |
Sponsors and Collaborators
- CID S.p.A.
- Meditrial Europe Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- P12204