Renal Artery StenosisPhase 4NCT00711984
Comparison of Stenting Versus Best Medical Therapy for Treatment of Ostial Renal Artery Stenosis: a Trial in Patients With Advanced Atherosclerosis
A Phase 4 study testing Herkulink renal artery Stent and best medical therapy in people with Renal Artery Stenosis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Renal artery stenosis (RAS) usually refers to a disease of the large extra-renal arterial vessels and most frequently is caused by atherosclerotic obstructions. The prevalence of atherosclerotic RAS increases with age, male gender, traditional cardiovascular risk factors (hypertension, diabetes, smoking… 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?
- Herkulink renal artery Stent and best medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2004to not given
- Phase
- Phase 4
- 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
- PAD and unilateral ostial >60% RAS and hypertension
Who cannot join
- Conditions which imply RAS stenting (bilateral significant renal disease, single functioning kidney, or patients whose conditions cannot be managed medically or by intervention)
- Allergy to contrast agents or medication administered for best medical treatment (in particular ASA and statins)
Trial locations and contacts
1 site in 1 country.
Erich Minar, Prof. Dr. contact
Martin Schillinger, Prof. Dr. contact
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna
Vienna, 1090
Erich Minar, Prof.Dr.
Martin Schillinger, Prof.Dr.
About this study
Official title: Comparison of Stenting Versus Best Medical Therapy for Treatment of Ostial Renal Artery Stenosis: a Randomized Controlled Trial in Patients With Advanced Atherosclerosis.
Renal artery stenosis (RAS) usually refers to a disease of the large extra-renal arterial vessels and most frequently is caused by atherosclerotic obstructions. The prevalence of atherosclerotic RAS increases with age, male gender, traditional cardiovascular risk factors (hypertension, diabetes, smoking, hyperlipidemia) and atherosclerotic comorbidities like coronary artery or peripheral artery disease (PAD). A prevalence up to 40% has been reported in patients with PAD. Undoubtedly, atherosclerotic RAS is a progressive disease, as more than half of the patients exhibit an increasing degree of stenosis within five years after diagnosis, and one out of five patients with a critical stenosis (>60%) suffers renal atrophy and renal failure during this period. RAS may be treated conservatively by so called best medical treatment, surgically, or by endovascular interventions using balloon angioplasty and stenting.
The purpose of the investigators study is to determine the incidence and the predictors of RAS in patients with PAD, and to compare the effect of renal artery stenting versus best medical treatment in patients with hypertension and ostial renal artery stenosis in a randomized controlled trial.
- Conditions
- Renal Artery Stenosis
- Being tested
- Herkulink renal artery Stent, best medical therapy
- Keywords
- renal artery stenosis, stent, comparison of treatments, progression, atherosclerosis, peripheral artery disease, major cardiovascular events
- Medical subject headings
- Renal Artery Obstruction, Disease Progression, Atherosclerosis, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herkulink renal artery StentDevice
Also called Herkulink (renal stent) Guidant/Abbott Vascular
renal artery stent
best medical therapyOther
All patients will receive best medical therapy according to current guidelines consisting in antihypertensive, antiplatelet, antidiabetic and lipid-lowering medication and in recommendation of lifestyle modification
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Renal artery stenting and Best medical treatment Receives: Device: Herkulink renal artery Stent; Other: best medical therapy |
| 2 | Active comparator | Best medical treatment alone Receives: Other: best medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in mean blood pressure and renal function occurrence of major cardiovascular events
Measured: 3, 6, 9, 12 months, annually
Secondary outcomes (1)
progression of the degree of RAS in the conservative group and restenosis rate in the stent group
Measured: 6, 12 months, annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Artery StenosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711984
- Sponsor's protocol ID
- Version 1.0-2003
- Status last verified
- Jul 2011
- First submitted
- 3 Jul 2008
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Stenting Versus Best Medical Therapy for Treatment of Ostial Renal Artery Stenosis: a Randomized Controlled Trial in Patients With Advanced Atherosclerosis.
- ClinicalTrials.gov ID
- NCT00711984
- Acronym / sponsor ID
- Version 1.0-2003
- Conditions
- Renal Artery Stenosis
- Keywords
- renal artery stenosis, stent, comparison of treatments, progression, atherosclerosis, peripheral artery disease, major cardiovascular events
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2004
- First posted
- 9 Jul 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.
Renal artery stenosis (RAS) usually refers to a disease of the large extra-renal arterial vessels and most frequently is caused by atherosclerotic obstructions. The prevalence of atherosclerotic RAS increases with age, male gender, traditional cardiovascular risk factors (hypertension, diabetes, smoking, hyperlipidemia) and atherosclerotic comorbidities like coronary artery or peripheral artery disease (PAD). A prevalence up to 40% has been reported in patients with PAD. Undoubtedly, atherosclerotic RAS is a progressive disease, as more than half of the patients exhibit an increasing degree of stenosis within five years after diagnosis, and one out of five patients with a critical stenosis (>60%) suffers renal atrophy and renal failure during this period. RAS may be treated conservatively by so called best medical treatment, surgically, or by endovascular interventions using balloon angioplasty and stenting.
The purpose of the investigators study is to determine the incidence and the predictors of RAS in patients with PAD, and to compare the effect of renal artery stenting versus best medical treatment in patients with hypertension and ostial renal artery stenosis in a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Herkulink renal artery Stent, Other: best medical therapyRenal artery stenting and Best medical treatment |
| 2 | Active comparator | Other: best medical therapyBest medical treatment alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PAD and unilateral ostial >60% RAS and hypertension
Key exclusion criteria (2 listed)
- Conditions which imply RAS stenting (bilateral significant renal disease, single functioning kidney, or patients whose conditions cannot be managed medically or by intervention)
- Allergy to contrast agents or medication administered for best medical treatment (in particular ASA and statins)
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 |
|---|---|---|
| Herkulink renal artery StentAlso: Herkulink (renal stent) Guidant/Abbott Vascularrenal artery stent | Device | 1 |
| best medical therapyAll patients will receive best medical therapy according to current guidelines consisting in antihypertensive, antiplatelet, antidiabetic and lipid-lowering medication and in recommendation of lifestyle modification | Other | 1, 2 |
Primary outcome
change in mean blood pressure and renal function occurrence of major cardiovascular events
Time frame: 3, 6, 9, 12 months, annually
1 secondary outcome
progression of the degree of RAS in the conservative group and restenosis rate in the stent group
Time frame: 6, 12 months, annually
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
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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.
Erich Minar, Prof. Dr. contact
Martin Schillinger, Prof. Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Herkulink renal artery Stent and best medical therapy in people with Renal Artery Stenosis, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 2 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 26 Jul 2011. 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 Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Erich Minar, Prof. Dr. (erich.minar@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in mean blood pressure and renal function occurrence of major cardiovascular events (time frame: 3, 6, 9, 12 months, annually). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2011.