Trials / Unknown
UnknownNCT05612438
RADIX 2 RENAL STENT Post-Market Retrospective Study
RADIX 2 RENAL ARTERY STENT Evaluation of Safety and Performance in Everyday Clinical Practice: Post-Market Retrospective Study.
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- CID S.p.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-03-03
- Primary completion
- 2023-07-30
- Completion
- 2023-08-30
- First posted
- 2022-11-10
- Last updated
- 2022-11-10
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05612438. Inclusion in this directory is not an endorsement.