Renal Artery StenosisPhase 3RADARNCT00640406
Comparison of Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting
A Phase 3 study testing Dynamic Renal Stent plus Best Medical Treatment and Best Medical Treatment in people with Renal Artery Stenosis, run by Biotronik AG at 1 site in Germany.
Trial summary
The clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow ups at 2, 6, 12 months and 3 years. The purpose of the study is to evaluate the clinical impact of percutaneous transluminal renal artery stenting (PTRAS) on the impaired renal function measured by the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Artery Stenosis
- What is being tested?
- Dynamic Renal Stent plus Best Medical Treatment and Best Medical Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Mar 2015
- Phase
- Phase 3
- 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
Who may be able to join
- Age ≥ 18 years
- Informed consent signed by patient (and/or legal guardian),
- Hemodynamically relevant de novo unilateral or bilateral atherosclerotic renal artery diameter stenosis RAS (≥ 70%)
- Estimated GFR > 10 ml/min calculated using the abbreviated Modification of Diet in Renal Disease (MDRD) Study equation,
- Patients presenting mild, moderate or severe hypertension (defined according to the WHO guidelines) and/or renal dysfunction,
- Target lesion must be completely coverable by one study stent,
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- Total target lesion length estimated to be less than 19 mm,
- Target lesion accessible to direct stenting or, after pre-dilation, is likely to sufficiently benefit from stenting (at the discretion of the investigator),
- Renal reference vessel diameter (RVD) of ≥ 4.0 mm and < 7.0 mm based on visual estimation,
- Willingness to comply with all the specified follow-up evaluations.
Who cannot join
- Estimated GFR ≤ 10 ml/min,
- Renal atrophy or kidney length < 7cm (referring to kidney with target lesion),
- Patient not eligible for PTRAS,
- Patient not eligible for stenting,
- Target lesion occlusion,
- Target lesion and/or target vessel proximal to the target lesion is severely calcified,
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- Treatment of branch lesion required,
- Fresh thrombus or embolic lesion
- Need for embolic protection in previous or planned PTRAS,
- Clotting disorders,
- INR > 2.5 before the intervention,
- Patient presents fibromuscular dysplasia,
- Prior revascularization of target lesion,
- History of target vessel revascularization within the last six months,
- Angiographic restenosis of any segment of the target vessel that has undergone prior percutaneous intervention,
- Any thrombolytic therapy procedure within 72 hours prior to planned study procedure
- Active peptic ulcer or gastro intestinal bleeding,
- Active inflammation of the kidney interfering with diagnosis and treatment of RAS (e.g. glomerulonephritis, aortitis, vasculitis),
- Radiation damage of the kidney,
- Renal disease associated with aortic aneurysm i.e. diameter of the aorta > 40 mm,
- Chronic renal replacement therapy,
- Life expectancy < 1 year,
- Co-morbid conditions limiting participation and follow-up
- Patient currently participating in another trial possibly influencing the safety of the patient and/or the outcomes of the study,
- Pregnancy/Planned pregnancy/Childbearing potential without sufficient measures to prevent pregnancy as judged by the investigator,
- Known allergy to contrast medium that cannot be adequately controlled with pre-medication,
- Known intolerance against acetylic-salicylic acid (ASA), heparin, clopidogrel and ticlopidin, cobalt-chromium,
- Metformin intake not stopped at least 48 hours before the intervention
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herzzentrum Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, 79189
About this study
Official title: A Randomized, Multi-centre, Prospective Study Comparing Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting in Patients With Hemodynamically Relevant Atherosclerotic Renal Artery Stenosis
The clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow ups at 2, 6, 12 months and 3 years.
The purpose of the study is to evaluate the clinical impact of percutaneous transluminal renal artery stenting (PTRAS) on the impaired renal function measured by the estimated Glomerular Filtration Rate (eGFR) in patients with hemodynamically significant atherosclerotic renal artery stenosis (ARAS).
- Conditions
- Renal Artery Stenosis
- Being tested
- Dynamic Renal Stent plus Best Medical Treatment, Best Medical Treatment
- Medical subject headings
- Renal Artery Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Renal Stent plus Best Medical TreatmentDevice
percutaneous transluminal angioplasty of the kidney artery at index procedure followed by best medical treatment for hypertension secondary to renal artery stenosis according to local standards
Best Medical TreatmentDrug
best medical treatment for hypertension secondary to renal artery stenosis according to local standards
| Study group | Role | What they receive |
|---|---|---|
| STN | Experimental | Device: Dynamic Renal Stent plus Best Medical Treatment Receives: Device: Dynamic Renal Stent plus Best Medical Treatment |
| BMT | Active comparator | Drug: Best Medical Treatment Receives: Drug: Best Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between treatments in change of estimated glomerular filtration rate (eGFR)
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 posted21 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2011
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Zeller, PD Dr. med, Principal investigator, Dep. of Angiology, Herzzentrum Bad Krozingen, Südring 15, 79189 Bad Krozingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640406
- Sponsor's protocol ID
- C0701
- Acronym
- RADAR
- Status last verified
- Jul 2015
- First submitted
- 17 Mar 2008
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zeller T, Krankenberg H, Erglis A, Blessing E, Fuss T, Scheinert D, Weser R, Doerr BB, Yollo WD, Radermacher J; RADAR Investigators. A randomized, multi-center, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with hemodynamically relevant atherosclerotic renal artery stenosis (RADAR) - one-year results of a pre-maturely terminated study. Trials. 2017 Aug 14;18(1):380. doi: 10.1186/s13063-017-2126-x.
PubMed 28807045Schwarzwalder U, Hauk M, Zeller T. RADAR - A randomised, multi-centre, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with haemodynamically relevant atherosclerotic renal artery stenosis. Trials. 2009 Jul 27;10:60. doi: 10.1186/1745-6215-10-60.
PubMed 19635148
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-centre, Prospective Study Comparing Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting in Patients With Hemodynamically Relevant Atherosclerotic Renal Artery Stenosis
- ClinicalTrials.gov ID
- NCT00640406
- Acronym / sponsor ID
- RADAR / C0701
- Conditions
- Renal Artery Stenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Mar 2008 (estimated)
- 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 clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow ups at 2, 6, 12 months and 3 years.
The purpose of the study is to evaluate the clinical impact of percutaneous transluminal renal artery stenting (PTRAS) on the impaired renal function measured by the estimated Glomerular Filtration Rate (eGFR) in patients with hemodynamically significant atherosclerotic renal artery stenosis (ARAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STN | Experimental | Device: Dynamic Renal Stent plus Best Medical TreatmentDevice: Dynamic Renal Stent plus Best Medical Treatment |
| BMT | Active comparator | Drug: Best Medical TreatmentDrug: Best Medical Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years
- Informed consent signed by patient (and/or legal guardian),
- Hemodynamically relevant de novo unilateral or bilateral atherosclerotic renal artery diameter stenosis RAS (≥ 70%)
- Estimated GFR > 10 ml/min calculated using the abbreviated Modification of Diet in Renal Disease (MDRD) Study equation,
- Patients presenting mild, moderate or severe hypertension (defined according to the WHO guidelines) and/or renal dysfunction,
Key exclusion criteria (28 listed)
- Estimated GFR ≤ 10 ml/min,
- Renal atrophy or kidney length < 7cm (referring to kidney with target lesion),
- Patient not eligible for PTRAS,
- Patient not eligible for stenting,
- Target lesion occlusion,
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 |
|---|---|---|
| Dynamic Renal Stent plus Best Medical Treatmentpercutaneous transluminal angioplasty of the kidney artery at index procedure followed by best medical treatment for hypertension secondary to renal artery stenosis according to local standards | Device | STN |
| Best Medical Treatmentbest medical treatment for hypertension secondary to renal artery stenosis according to local standards | Drug | BMT |
Primary outcome
Difference between treatments in change of estimated glomerular filtration rate (eGFR)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
- Derived from this study: PubMed 28807045Zeller T, Krankenberg H, Erglis A, Blessing E, Fuss T, Scheinert D, Weser R, Doerr BB, Yollo WD, Radermacher J; RADAR Investigators. A randomized, multi-center, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with hemodynamically relevant atherosclerotic renal artery stenosis (RADAR) - one-year results of a pre-maturely terminated study. Trials. 2017 Aug 14;18(1):380. doi: 10.1186/s13063-017-2126-x.
- Derived from this study: PubMed 19635148Schwarzwalder U, Hauk M, Zeller T. RADAR - A randomised, multi-centre, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with haemodynamically relevant atherosclerotic renal artery stenosis. Trials. 2009 Jul 27;10:60. doi: 10.1186/1745-6215-10-60.
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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.
Thomas Zeller, PD Dr. med principal investigator
Dep. of Angiology, Herzzentrum Bad Krozingen, Südring 15, 79189 Bad Krozingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dynamic Renal Stent plus Best Medical Treatment and Best Medical Treatment in people with Renal Artery Stenosis, run by Biotronik AG at 1 site in Germany.
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 10 inclusion and 28 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: finished, as of the sponsor's last update on 21 Jul 2015. 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 Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between treatments in change of estimated glomerular filtration rate (eGFR) (time frame: 12 months). 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 NCT00640406, which also lists 2 linked publications.
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 21 Jul 2015.