Renal Artery ObstructionPhase 2/3NCT00868972
Renal Stenting With Distal Atheroembolic Protection
A Phase 2/3 study testing Percutaneous renal stenting intervention and Distal embolic protection in people with Renal Artery Obstruction and Renovascular Hypertension, run by Universita di Verona at 1 site in Italy.
Trial summary
Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal function, refractory hypertension and flushing edema, responsible for mortality and morbidity, especially in the elderly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Artery Obstruction, Renovascular Hypertension
- What is being tested?
- Percutaneous renal stenting intervention and Distal embolic protection
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2009to Sep 2011
- Phase
- Phase 2/3
- 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
- Ostial atherosclerotic renal artery stenosis ≥70% on intra-arterial angiography
- Well documented history of hypertension (>140/90 mmHg) non responsive to the use of 2 or more antihypertensive medications and/or
- Estimated glomerular filtration rate <60 ml/min/1.73m2 according to the MDRD formula, on two occasions within one month
Who cannot join
- Declined informed consent
- Renal longitudinal diameter < 8 cm
- Any anatomical reasons that make impossible the PTRA and or the positioning of the distal embolic protection device
- Estimated glomerular filtration rate <30 ml/min/1.73m2 according to the MDRD formula or on dialysis
- Allergy to the contrast medium used during angiography
- Other conditions associated with (within 6 months) poor prognosis
- Myocardial infarction, unstable angina or stroke <1 month before planned date of inclusion
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera di Verona, Policlinico G.B. Rossi
Verona, 37134
Giancarlo Mansueto, MD, professor
About this study
Official title: Percutaneous Renal Stenting in Renovascular Disease With or Without Distal Atheroembolic Protection
Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal function, refractory hypertension and flushing edema, responsible for mortality and morbidity, especially in the elderly. Current treatment includes restoration of the renal arterial lumen by endovascular stent placement and/or intensive medical therapy. There is no unanimous consent on which patients could benefice of the endovascular procedure due to the high rate of renal adverse events especially linked to atheroembolic disease. Recently, renal revascularization using a device which consents distal embolic protection of the kidney demonstrated to be a "safe" auxiliary procedure in a few non randomized studies. Interestingly atheromatous debris was detected in 60 to 80% of these devices analyzed after the procedure suggesting that these devices could prevent atheroembolism in a substantial proportion of patients. On the other hand, only a randomized controlled study can prove that renal stent with distal embolic protection is superior to renal stent alone in preserving kidney function.
Therefore, the present study aims to compare the effects of renal artery stent placement with or without distal embolic protection on renal function in ARAS patients.
Read more
Method:
Patients with an ARAS of ≥70% and hypertension not responsive to at least 2 antihypertensive medications and/or renal failure (estimated GFR <60 mL/min/1.73 m2 are randomly assigned to stent placement alone or stent placement with distal embolic protection (FILTER WIRE EX; Cordis Endovascular, USA).
Other medications consist of statins, anti-hypertensive drugs and antiplatelet therapy. Patients are followed for 3 months. The primary outcome of this study is a statistical significant difference in kidney function measured as Cr clearance and cystatin C level in the 2 groups at three months. The trial will include 150 patients.
Read the detailed description
This is a randomized trial of patients with an ostial ARAS and refractory hypertension and or renal failure. Patients will be randomized to:
(i) renal artery stent placement with distal embolic protection (ii) renal artery stent placement without distal embolic protection To both groups an optimal medical treatment consisting of antihypertensive, lipid-lowering and antiplatelet therapy will be added.
Patients with an ostial ARAS associated with an estimated GFR of <60 mL/min/1.73m2 according to the MDRD formula and/or refractory hypertension are enrolled in this trial. Ostial ARAS is defined as a luminal reduction of ≥70% of the renal artery within 1 cm of the aortic wall, in the presence of atherosclerotic changes of the aorta. Stenosis evaluation can be performed on intra-arterial angiography.
Medical therapy: Irrespective of baseline serum cholesterol values, the patients will be treated with lipid-lowering therapy: 10 mg of rosuvastatin. Any lipid-lowering medication currently used is discontinued and replaced by rosuvastatin. Hypertension is treated with the following drugs: ACE-inhibitors together, loop diuretic, dihydropyridine calcium antagonists. The target BP is <140/90 mmHg. Patients will receive anti-platelet therapy, aspirin 75-100 mg/od plus ticlopidine 250 mg bid for one month. Considering that smoking is a major renal risk factor, smokers will be advised to stop.
Medical therapy is identical in the two treatment arms. In both groups patients will start with aspirin 100 mg/od and ticlopidine 250 mg bid at least five days before admission. The stent (Palmaz-Corinthian IQ/Palmaz Genesis, Johnson \& Johnson Medical, NV/SA) will be placed during an in-patient admission according to a standardized protocol. To Patients randomized to the embolic protection the device (FILTER WIRE EX; Cordis Endovascular, USA) will be placed distal to the arterial stenosis before stent placement.
Randomization will be done using random numbers tables The only people aware of the assigned procedure will be the radiologists' team. Researchers and technicians who will follow the patients and analyze the plasma and urinary samples will be blinded to the assigned treatment.
Clinical follow-up is scheduled after 1 and 3 months. Analysis of results: The difference in the mean change of cystatin C respect to baseline between both treatment arms will be assessed including 95% confidence intervals (95% CI). The effects on renal function of the two treatment strategies will be evaluated with multivariate linear regression analysis, considering also the eventual role of age, smoking, diabetes, lipids level, proteinuria, bilateral or unilateral renal artery stenosis, BP and renal function at baseline
- Being tested
- Percutaneous renal stenting intervention, Distal embolic protection
- Keywords
- Renal Artery Obstruction, renovascular hypertension, stent, Kidney Failure, embolic protection
- Medical subject headings
- Renal Artery Obstruction, Hypertension, Renovascular, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous renal stenting interventionProcedure or surgery
Percutaneous renal stenting intervention
Distal embolic protectionDevice
Distal embolic protection device (filter wire ex; Cordis Endovascular, USA).
| Study group | Role | What they receive |
|---|---|---|
| Embolic protection | Active comparator | Percutaneous renal stenting using a distal embolic protection device (filter wire ex; Cordis Endovascular, USA). Receives: Procedure: Percutaneous renal stenting intervention; Device: Distal embolic protection |
| No embolic protection | Sham comparator | Percutaneous renal stenting intervention without embolic protection Receives: Procedure: Percutaneous renal stenting intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in renal function loss (measured as Cr clearance and/or cystatin C) after 1 and 3 months of follow-up
Measured: 3 months
Secondary outcomes (3)
Acute complications, especially atheroembolism
Measured: 3 months
Evaluations of the covariates associated with a better outcome in the atheroembolic device group
Measured: 3 months
Blood pressure control (number of medication needed to keep BP<140/90 )
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Artery ObstructionStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Investigators
- Giancarlo Mansueto, MD, professor, Principal investigator, Univerista di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868972
- Sponsor's protocol ID
- MOMPF-01
- Status last verified
- Jan 2010
- First submitted
- 24 Mar 2009
- Last updated
- 25 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Renal Stenting in Renovascular Disease With or Without Distal Atheroembolic Protection
- ClinicalTrials.gov ID
- NCT00868972
- Acronym / sponsor ID
- MOMPF-01
- Keywords
- Renal Artery Obstruction, renovascular hypertension, stent, Kidney Failure, embolic protection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 25 Mar 2009 (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.
Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal function, refractory hypertension and flushing edema, responsible for mortality and morbidity, especially in the elderly. Current treatment includes restoration of the renal arterial lumen by endovascular stent placement and/or intensive medical therapy. There is no unanimous consent on which patients could benefice of the endovascular procedure due to the high rate of renal adverse events especially linked to atheroembolic disease. Recently, renal revascularization using a device which consents distal embolic protection of the kidney demonstrated to be a "safe" auxiliary procedure in a few non randomized studies. Interestingly atheromatous debris was detected in 60 to 80% of these devices analyzed after the procedure suggesting that these devices could prevent atheroembolism in a substantial proportion of patients. On the other hand, only a randomized controlled study can prove that renal stent with distal embolic protection is superior to renal stent alone in preserving kidney function.
Therefore, the present study aims to compare the effects of renal artery stent placement with or without distal embolic protection on renal function in ARAS patients.
Method:
Patients with an ARAS of ≥70% and hypertension not responsive to at least 2 antihypertensive medications and/or renal failure (estimated GFR <60 mL/min/1.73 m2 are randomly assigned to stent placement alone or stent placement with distal embolic protection (FILTER WIRE EX; Cordis Endovascular, USA).
Other medications consist of statins, anti-hypertensive drugs and antiplatelet therapy. Patients are followed for 3 months. The primary outcome of this study is a statistical significant difference in kidney function measured as Cr clearance and cystatin C level in the 2 groups at three months. The trial will include 150 patients.
Detailed description
This is a randomized trial of patients with an ostial ARAS and refractory hypertension and or renal failure. Patients will be randomized to:
(i) renal artery stent placement with distal embolic protection (ii) renal artery stent placement without distal embolic protection To both groups an optimal medical treatment consisting of antihypertensive, lipid-lowering and antiplatelet therapy will be added.
Patients with an ostial ARAS associated with an estimated GFR of <60 mL/min/1.73m2 according to the MDRD formula and/or refractory hypertension are enrolled in this trial. Ostial ARAS is defined as a luminal reduction of ≥70% of the renal artery within 1 cm of the aortic wall, in the presence of atherosclerotic changes of the aorta. Stenosis evaluation can be performed on intra-arterial angiography.
Medical therapy: Irrespective of baseline serum cholesterol values, the patients will be treated with lipid-lowering therapy: 10 mg of rosuvastatin. Any lipid-lowering medication currently used is discontinued and replaced by rosuvastatin. Hypertension is treated with the following drugs: ACE-inhibitors together, loop diuretic, dihydropyridine calcium antagonists. The target BP is <140/90 mmHg. Patients will receive anti-platelet therapy, aspirin 75-100 mg/od plus ticlopidine 250 mg bid for one month. Considering that smoking is a major renal risk factor, smokers will be advised to stop.
Medical therapy is identical in the two treatment arms. In both groups patients will start with aspirin 100 mg/od and ticlopidine 250 mg bid at least five days before admission. The stent (Palmaz-Corinthian IQ/Palmaz Genesis, Johnson \& Johnson Medical, NV/SA) will be placed during an in-patient admission according to a standardized protocol. To Patients randomized to the embolic protection the device (FILTER WIRE EX; Cordis Endovascular, USA) will be placed distal to the arterial stenosis before stent placement.
Randomization will be done using random numbers tables The only people aware of the assigned procedure will be the radiologists' team. Researchers and technicians who will follow the patients and analyze the plasma and urinary samples will be blinded to the assigned treatment.
Clinical follow-up is scheduled after 1 and 3 months. Analysis of results: The difference in the mean change of cystatin C respect to baseline between both treatment arms will be assessed including 95% confidence intervals (95% CI). The effects on renal function of the two treatment strategies will be evaluated with multivariate linear regression analysis, considering also the eventual role of age, smoking, diabetes, lipids level, proteinuria, bilateral or unilateral renal artery stenosis, BP and renal function at baseline
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embolic protection | Active comparator | Procedure: Percutaneous renal stenting intervention, Device: Distal embolic protectionPercutaneous renal stenting using a distal embolic protection device (filter wire ex; Cordis Endovascular, USA). |
| No embolic protection | Sham comparator | Procedure: Percutaneous renal stenting interventionPercutaneous renal stenting intervention without embolic protection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- Ostial atherosclerotic renal artery stenosis ≥70% on intra-arterial angiography
- Well documented history of hypertension (>140/90 mmHg) non responsive to the use of 2 or more antihypertensive medications and/or
- Estimated glomerular filtration rate <60 ml/min/1.73m2 according to the MDRD formula, on two occasions within one month
Key exclusion criteria (7 listed)
- Declined informed consent
- Renal longitudinal diameter < 8 cm
- Any anatomical reasons that make impossible the PTRA and or the positioning of the distal embolic protection device
- Estimated glomerular filtration rate <30 ml/min/1.73m2 according to the MDRD formula or on dialysis
- Allergy to the contrast medium used during angiography
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 |
|---|---|---|
| Percutaneous renal stenting interventionPercutaneous renal stenting intervention | Procedure or surgery | Embolic protection, No embolic protection |
| Distal embolic protectionDistal embolic protection device (filter wire ex; Cordis Endovascular, USA). | Device | Embolic protection |
Primary outcome
Differences in renal function loss (measured as Cr clearance and/or cystatin C) after 1 and 3 months of follow-up
Time frame: 3 months
3 secondary outcomes
Acute complications, especially atheroembolism
Time frame: 3 months
Evaluations of the covariates associated with a better outcome in the atheroembolic device group
Time frame: 3 months
Blood pressure control (number of medication needed to keep BP<140/90 )
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2010.
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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.
Giancarlo Mansueto, MD, professor principal investigator
Univerista di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Percutaneous renal stenting intervention and Distal embolic protection in people with Renal Artery Obstruction and Renovascular Hypertension, run by Universita di Verona 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 7 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 25 Jan 2010. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giancarlo Mansueto, MD, professor (00390458124301, giancarlo.mansueto@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in renal function loss (measured as Cr clearance and/or cystatin C) after 1 and 3 months of follow-up (time frame: 3 months). 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 25 Jan 2010.