Renal Artery StenosisRADIX 2NCT05612438
RADIX 2 RENAL STENT Post-Market Retrospective Study
An observational study of Renal Artery Stenosis and Renal Failure, run by CID S.p.A. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Artery Stenosis, Renal Failure
- What is being tested?
- RADIX 2 Stent
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 3 Mar 2023to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
- Patients treated less than 12 months prior to study start
Trial locations and contacts
1 site in 1 country.
Monica Tocchi, MD contact
Italy1 site
Centro Cardiologico Monzino
Milan
Pietro Montorsi, MD, invasiva1@cardiologicomonzino.it
About this study
Official title: RADIX 2 RENAL ARTERY STENT Evaluation of Safety and Performance in Everyday Clinical Practice: Post-Market Retrospective Study.
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.
Read the 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
- Renal Artery Stenosis, Renal Failure
- Being tested
- RADIX 2 Stent
- Medical subject headings
- Renal Artery Obstruction, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RADIX 2 StentDevice
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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (4)
Acute device success
Acute Device Success, defined as the successful delivery of the assigned device(s) to the designated target location
Measured: 24 hours
Technical success
Technical Success, defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30%
Measured: 24 hours
In Stent Restenosis
Restenosis of Radix2 stent, requiring repeat revascularization
Measured: 12 months
Arterial Blood Pressure
Systolic and diastolic arterial blood pressure changes during follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start3 Mar 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CID S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612438
- Sponsor's protocol ID
- P12204
- Acronym
- RADIX 2
- Status last verified
- Nov 2022
- First submitted
- 4 Nov 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16212462
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADIX 2 RENAL ARTERY STENT Evaluation of Safety and Performance in Everyday Clinical Practice: Post-Market Retrospective Study.
- ClinicalTrials.gov ID
- NCT05612438
- Acronym / sponsor ID
- RADIX 2 / P12204
- Conditions
- Renal Artery Stenosis, Renal Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CID S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Study start
- 3 Mar 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- The study will be conducted in the "real world" population, according to the following 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.
Key exclusion criteria (1 listed)
- Patients treated less than 12 months prior to study start
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RADIX 2 StentRADIX 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. | Device | – |
Primary outcome
Major renal events
Time frame: 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.
4 secondary outcomes
Acute device success
Time frame: 24 hours
Technical success
Time frame: 24 hours
In Stent Restenosis
Time frame: 12 months
Arterial Blood Pressure
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Background: PubMed 16212462Zeller 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.
- Manufacturer websiteLink provided by the sponsor.
- Clinical Research OrganizationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Tocchi, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Artery Stenosis and Renal Failure, run by CID S.p.A. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franco Vallana, MD (+39 0161 18261, franco.vallana@alvimedica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major renal events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05612438, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.