Renal Artery StenosisPhase 2NCT00234585
Prospective Randomized Study Comparing Renal Artery Stenting (RESIST)With/Without Distal Protection
A Phase 2 study testing Renal Artery Stent with Protective Device/Drug in people with Renal Artery Stenosis, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
This study is designed to demonstrate the safety and efficacy of using a protective device/drug to prevent renal injury during renal artery stenting and to assess whether the preventative effects are measurable and if there is a differential treatment effect for either device alone or in combination. 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?
- Renal Artery Stent with Protective Device/Drug
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Jun 2007
- Phase
- Phase 2
- 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
- Any one or more of the following:
- Meet Angiographic criteria plus
- Systemic hypertension at baseline, or a history of hypertension
- Congestive heart failure at baseline, or a history of CHF
- Renal insufficiency at baseline, or a history of renal insufficiency
- Angina, or a history of angina
Who cannot join
- Less than 18 years old
- Contraindications to device/drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Multicenter Study Comparing the Safety and Efficacy of Renal Artery Stenting With/Without Distal Protection Device (AngioGuard) and With/Without the Use of a Platelet Aggregator Inhibitor (Abciximab-Reopro) (RESIST)
This study is designed to demonstrate the safety and efficacy of using a protective device/drug to prevent renal injury during renal artery stenting and to assess whether the preventative effects are measurable and if there is a differential treatment effect for either device alone or in combination.
Read the detailed description
This study is designed to demonstrate the safety and efficacy of using protective device/drug to prevent renal injury during renal artery stenting (RAS) and to assess whether the preventative effects are measurable, and if there is a differential treatment effect for either device alone or in combination.
Specific goals of the study include:
- To establish device and drug safety
- To identify appropriate markers for renal injury
- To measure effectiveness of drug and device
- To enable the design of FDA efficacy trials for renal artery stenting inclusive of device and or drug
The study will address the four following hypotheses:
- AngioGuard™ distal protection device provides significant protection from atheroembolization during RAS procedures as measured by affected kidney GFR at 1 month after the procedure.
- Abciximab (ReoPro) offers protection against platelet aggregation and embolization as measured by affected kidney GFR at 1 month after the procedure.
- AngioGuard™ and Abciximab are safe, alone and in combination.
- Is there an interaction effect between AngioGuard™ and ReoPro for efficacy and safety?
- Conditions
- Renal Artery Stenosis
- Being tested
- Renal Artery Stent with Protective Device/Drug
- 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.
Renal Artery Stent with Protective Device/DrugDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular Filtration Rate
Adverse Events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startAug 2002
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor, Inc., Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Christopher Cooper, M.D., Principal investigator, Medical University of Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234585
- Sponsor's protocol ID
- xMUO-01
- Status last verified
- Dec 2014
- First submitted
- 5 Oct 2005
- Last updated
- 10 Dec 2014
- Results posted
- No
Publications
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
PubMed 35224730Yu H, Zhang D, Haller S, Kanjwal K, Colyer W, Brewster P, Steffes M, Shapiro JI, Cooper CJ. Determinants of renal function in patients with renal artery stenosis. Vasc Med. 2011 Oct;16(5):331-8. doi: 10.1177/1358863X11419998. Epub 2011 Sep 9.
PubMed 21908683Tian J, Haller S, Periyasamy S, Brewster P, Zhang H, Adlakha S, Fedorova OV, Xie ZJ, Bagrov AY, Shapiro JI, Cooper CJ. Renal ischemia regulates marinobufagenin release in humans. Hypertension. 2010 Nov;56(5):914-9. doi: 10.1161/HYPERTENSIONAHA.110.155564. Epub 2010 Sep 7.
PubMed 20823380Kanjwal K, Cooper CJ, Virmani R, Haller S, Shapiro JI, Burket MW, Steffes M, Brewster P, Zhang H, Colyer WR Jr. Predictors of embolization during protected renal artery angioplasty and stenting: Role of antiplatelet therapy. Catheter Cardiovasc Interv. 2010 Jul 1;76(1):16-23. doi: 10.1002/ccd.22469.
PubMed 20209644Kanjwal K, Haller S, Steffes M, Virmani R, Shapiro JI, Burket MW, Cooper CJ, Colyer WR Jr. Complete versus partial distal embolic protection during renal artery stenting. Catheter Cardiovasc Interv. 2009 May 1;73(6):725-30. doi: 10.1002/ccd.21932.
PubMed 19198007Cooper CJ, Haller ST, Colyer W, Steffes M, Burket MW, Thomas WJ, Safian R, Reddy B, Brewster P, Ankenbrandt MA, Virmani R, Dippel E, Rocha-Singh K, Murphy TP, Kennedy DJ, Shapiro JI, D'Agostino RD, Pencina MJ, Khuder S. Embolic protection and platelet inhibition during renal artery stenting. Circulation. 2008 May 27;117(21):2752-60. doi: 10.1161/CIRCULATIONAHA.107.730259. Epub 2008 May 19.
PubMed 18490527
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multicenter Study Comparing the Safety and Efficacy of Renal Artery Stenting With/Without Distal Protection Device (AngioGuard) and With/Without the Use of a Platelet Aggregator Inhibitor (Abciximab-Reopro) (RESIST)
- ClinicalTrials.gov ID
- NCT00234585
- Acronym / sponsor ID
- xMUO-01
- Conditions
- Renal Artery Stenosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Collaborators
- Centocor, Inc., Johnson & Johnson
- Study start
- Aug 2002
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 7 Oct 2005 (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.
This study is designed to demonstrate the safety and efficacy of using a protective device/drug to prevent renal injury during renal artery stenting and to assess whether the preventative effects are measurable and if there is a differential treatment effect for either device alone or in combination.
Detailed description
This study is designed to demonstrate the safety and efficacy of using protective device/drug to prevent renal injury during renal artery stenting (RAS) and to assess whether the preventative effects are measurable, and if there is a differential treatment effect for either device alone or in combination.
Specific goals of the study include:
- To establish device and drug safety
- To identify appropriate markers for renal injury
- To measure effectiveness of drug and device
- To enable the design of FDA efficacy trials for renal artery stenting inclusive of device and or drug
The study will address the four following hypotheses:
- AngioGuard™ distal protection device provides significant protection from atheroembolization during RAS procedures as measured by affected kidney GFR at 1 month after the procedure.
- Abciximab (ReoPro) offers protection against platelet aggregation and embolization as measured by affected kidney GFR at 1 month after the procedure.
- AngioGuard™ and Abciximab are safe, alone and in combination.
- Is there an interaction effect between AngioGuard™ and ReoPro for efficacy and safety?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meet Angiographic criteria plus
- Systemic hypertension at baseline, or a history of hypertension
- Congestive heart failure at baseline, or a history of CHF
- Renal insufficiency at baseline, or a history of renal insufficiency
- Angina, or a history of angina
Key exclusion criteria (2 listed)
- Less than 18 years old
- Contraindications to device/drug
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 |
|---|---|---|
| Renal Artery Stent with Protective Device/Drug | Device | – |
Primary outcome
Glomerular Filtration Rate
Adverse Events
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 10 Dec 2014.
- Derived from this study: PubMed 35224730Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
- Derived from this study: PubMed 21908683Yu H, Zhang D, Haller S, Kanjwal K, Colyer W, Brewster P, Steffes M, Shapiro JI, Cooper CJ. Determinants of renal function in patients with renal artery stenosis. Vasc Med. 2011 Oct;16(5):331-8. doi: 10.1177/1358863X11419998. Epub 2011 Sep 9.
- Derived from this study: PubMed 20823380Tian J, Haller S, Periyasamy S, Brewster P, Zhang H, Adlakha S, Fedorova OV, Xie ZJ, Bagrov AY, Shapiro JI, Cooper CJ. Renal ischemia regulates marinobufagenin release in humans. Hypertension. 2010 Nov;56(5):914-9. doi: 10.1161/HYPERTENSIONAHA.110.155564. Epub 2010 Sep 7.
- Derived from this study: PubMed 20209644Kanjwal K, Cooper CJ, Virmani R, Haller S, Shapiro JI, Burket MW, Steffes M, Brewster P, Zhang H, Colyer WR Jr. Predictors of embolization during protected renal artery angioplasty and stenting: Role of antiplatelet therapy. Catheter Cardiovasc Interv. 2010 Jul 1;76(1):16-23. doi: 10.1002/ccd.22469.
- Derived from this study: PubMed 19198007Kanjwal K, Haller S, Steffes M, Virmani R, Shapiro JI, Burket MW, Cooper CJ, Colyer WR Jr. Complete versus partial distal embolic protection during renal artery stenting. Catheter Cardiovasc Interv. 2009 May 1;73(6):725-30. doi: 10.1002/ccd.21932.
- Derived from this study: PubMed 18490527Cooper CJ, Haller ST, Colyer W, Steffes M, Burket MW, Thomas WJ, Safian R, Reddy B, Brewster P, Ankenbrandt MA, Virmani R, Dippel E, Rocha-Singh K, Murphy TP, Kennedy DJ, Shapiro JI, D'Agostino RD, Pencina MJ, Khuder S. Embolic protection and platelet inhibition during renal artery stenting. Circulation. 2008 May 27;117(21):2752-60. doi: 10.1161/CIRCULATIONAHA.107.730259. Epub 2008 May 19.
Related trials for Renal Artery Stenosis
RecruitingObservational study
Vascular Complications After Kidney Transplantation
Kidney Transplant Recipient, Kidney Transplant; Complications
Active, not recruitingObservational study
Mortality Outcome of Controlled Hypertension
Hypertension, Morality
Not yet recruitingPhase 4
Effect of Secukinumab on Cardiorenal Outcomes in Patients With Cardiorenal Metabolic Syndrome and Atherosclerotic Cardiovascular Disease
Cardiorenal Metabolic Syndrome, Atherosclerotic Cardiovascular Disease
Not yet recruiting
Covered vs Bare Metal Stents for Atherosclerotic Renal Artery Stenosis
Atherosclerotic Renal Artery Stenosis, Hypertension
Not yet recruiting
FFR-Guided Revascularization in Atherosclerotic Renal Artery Stenosis
Atherosclerotic Renal Artery Stenosis, Fractional Flow Reserve
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.
Christopher Cooper, M.D. principal investigator
Medical University of Ohio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Renal Artery Stent with Protective Device/Drug in people with Renal Artery Stenosis, run by University of Toledo Health Science Campus at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 10 Dec 2014. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Glomerular Filtration Rate. The study lists 2 primary outcomes in all. 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 NCT00234585, which also lists 6 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 10 Dec 2014.