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| Name | Class |
|---|---|
| Meditrial Europe Ltd. | INDUSTRY |
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The Carbostentâ„¢ 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-Carbofilmâ„¢ 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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RADIX 2 Stent | Device | 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. |
| 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 |
| 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% |
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Inclusion Criteria:
The study will be conducted in the "real world" population, according to the following criteria.
Selection criteria:
Exclusion Criteria:
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Patients affected with occlusive lesions of the native renal artery disease treated with the study stent, these patients are generally affected by cardiovascular comorbidities with a high incidence of mortality or in the terminal phase of the disease or in advanced age and in serious health conditions
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Franco Vallana, MD | Contact | +39 0161 18261 | franco.vallana@alvimedica.com | |
| Monica Tocchi, MD | Contact | m.tocchi@meditrial.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Cardiologico Monzino | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16212462 | Background | Zeller T, Rastan A, Kliem M, Schwarzwalder U, Frank U, Burgelin K, Schwarz T, Amantea P, Muller C, Neumann FJ. Impact of carbon coating on the restenosis rate after stenting of atherosclerotic renal artery stenosis. J Endovasc Ther. 2005 Oct;12(5):605-11. doi: 10.1583/05-1599MR.1. |
| Label | URL |
|---|---|
| Manufacturer website | View source |
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| ID | Term |
|---|---|
| D012078 | Renal Artery Obstruction |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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 |
| Clinical Research Organization | View source |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |