Renal Artery StenosisPhase 2GREATNCT00235157
A Comparison of Coated and Uncoated Stents in Renal Artery Treatment.
A Phase 2 study testing Sirolimus-eluting Palmaz Genesis peripheral stent in people with Renal Artery Stenosis, run by Cordis US Corp. at 3 sites in 3 countries.
Trial summary
The primary objective of this study is to compare the safety and performance of the Palmaz Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of renal artery stenosis, measured at 6 months follow up via angiography. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Renal Artery Stenosis
- What is being tested?
- Sirolimus-eluting Palmaz Genesis peripheral stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2001to Jul 2005
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical indication for renal artery revascularization of atherosclerotic renal artery stenosis >=50% as measured by operator or estimated original vessel diameter, based on healthy vessel segment and contralateral side.
- The reference vessel renal artery must be >= 4mm and <= 8 mm by visual estimate.
- The patient must have a baseline serum creatinine of <= 5.0 mg/dl.
Who cannot join
- Total occlusion of the renal artery.
- Lesions which would require more than 2 stents.
- Lesions which are in arteries to transplanted or bypassed kidneys.
- Abdominal aortic aneurysm > 4.0 cm in diameter.
- Patients with ASA classification >=4.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.
The primary objective of this study is to compare the safety and performance of the Palmaz Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of renal artery stenosis, measured at 6 months follow up via angiography.
Read the detailed description
Multi-center, prospective, controlled, non-randomized investigational feasibility study. One hundred (100) patients with de novo or restenotic renal artery lesions consisting of >= 50% stenosis and reference vessel of >= 4.0 to <= 8.0 mm in diameter will be sequentially included, 50 without sirolimus coating, followed by 50 with sirolimus coating Palmaz GenesisTM. Patients will be followed for 24 months post-procedure, with all patients having clinical assessments at discharge, 1,6, 12 and 24 months. This study will be conducted at twelve investigational sites.
It is anticipated that the total length of time required to complete the study will be 46 months.
- Conditions
- Renal Artery Stenosis
- Being tested
- Sirolimus-eluting Palmaz Genesis peripheral stent
- 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.
Sirolimus-eluting Palmaz Genesis peripheral stentDevice
Also called Palmaz Genesis Stent
treatment of renal artery stenosis with a renal stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sirolimus-eluting Palmaz Genesis peripheral stent Receives: Device: Sirolimus-eluting Palmaz Genesis peripheral stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of the angiographical in-stent minimal lumen diameter
Measured: 6-months follow up
Secondary outcomes (5)
clinical primary patency
Measured: discharge, 1, 6 and 12 months post-procedure
procedural success
Measured: post-procedure
worsening renal function
Measured: 30 days, 6 months, 12 months
change in blood pressure measurement
Measured: 30 days, 6 months, 12 months
significant embolic events causing end-organ damage
Measured: 30 days, 6 months, and 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 Oct 2005 (estimated)
- Study startNov 2001
- Primary completionNov 2002
- Study completionJul 2005
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Markus Zähringer, MD, Principal investigator, Universitätskliniken KölnMarc Sapoval, MD, Principal investigator, Hopital Européen Georges PompidouPeter M Pattynama, MD, Principal investigator, Erasmus MC Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235157
- Sponsor's protocol ID
- EE01-01
- Acronym
- GREAT
- Status last verified
- Aug 2008
- First submitted
- 6 Oct 2005
- Last updated
- 6 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zahringer M, Sapoval M, Pattynama PM, Rabbia C, Vignali C, Maleux G, Boyer L, Szczerbo-Trojanowska M, Jaschke W, Hafsahl G, Downes M, Beregi JP, Veeger NJ, Stoll HP, Talen A. Sirolimus-eluting versus bare-metal low-profile stent for renal artery treatment (GREAT Trial): angiographic follow-up after 6 months and clinical outcome up to 2 years. J Endovasc Ther. 2007 Aug;14(4):460-8. doi: 10.1177/152660280701400405.
PubMed 17696619
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.
- ClinicalTrials.gov ID
- NCT00235157
- Acronym / sponsor ID
- GREAT / EE01-01
- Conditions
- Renal Artery Stenosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- Nov 2002 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 10 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.
The primary objective of this study is to compare the safety and performance of the Palmaz Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of renal artery stenosis, measured at 6 months follow up via angiography.
Detailed description
Multi-center, prospective, controlled, non-randomized investigational feasibility study. One hundred (100) patients with de novo or restenotic renal artery lesions consisting of >= 50% stenosis and reference vessel of >= 4.0 to <= 8.0 mm in diameter will be sequentially included, 50 without sirolimus coating, followed by 50 with sirolimus coating Palmaz GenesisTM. Patients will be followed for 24 months post-procedure, with all patients having clinical assessments at discharge, 1,6, 12 and 24 months. This study will be conducted at twelve investigational sites.
It is anticipated that the total length of time required to complete the study will be 46 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Sirolimus-eluting Palmaz Genesis peripheral stentSirolimus-eluting Palmaz Genesis peripheral stent |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical indication for renal artery revascularization of atherosclerotic renal artery stenosis >=50% as measured by operator or estimated original vessel diameter, based on healthy vessel segment and contralateral side.
- The reference vessel renal artery must be >= 4mm and <= 8 mm by visual estimate.
- The patient must have a baseline serum creatinine of <= 5.0 mg/dl.
Key exclusion criteria (5 listed)
- Total occlusion of the renal artery.
- Lesions which would require more than 2 stents.
- Lesions which are in arteries to transplanted or bypassed kidneys.
- Abdominal aortic aneurysm > 4.0 cm in diameter.
- Patients with ASA classification >=4.
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 |
|---|---|---|
| Sirolimus-eluting Palmaz Genesis peripheral stentAlso: Palmaz Genesis Stenttreatment of renal artery stenosis with a renal stent | Device | 1 |
Primary outcome
assessment of the angiographical in-stent minimal lumen diameter
Time frame: 6-months follow up
5 secondary outcomes
clinical primary patency
Time frame: discharge, 1, 6 and 12 months post-procedure
procedural success
Time frame: post-procedure
worsening renal function
Time frame: 30 days, 6 months, 12 months
change in blood pressure measurement
Time frame: 30 days, 6 months, 12 months
significant embolic events causing end-organ damage
Time frame: 30 days, 6 months, and 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 6 Aug 2008.
- Results publication: PubMed 17696619Zahringer M, Sapoval M, Pattynama PM, Rabbia C, Vignali C, Maleux G, Boyer L, Szczerbo-Trojanowska M, Jaschke W, Hafsahl G, Downes M, Beregi JP, Veeger NJ, Stoll HP, Talen A. Sirolimus-eluting versus bare-metal low-profile stent for renal artery treatment (GREAT Trial): angiographic follow-up after 6 months and clinical outcome up to 2 years. J Endovasc Ther. 2007 Aug;14(4):460-8. doi: 10.1177/152660280701400405.
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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.
Markus Zähringer, MD principal investigator
Universitätskliniken Köln
Marc Sapoval, MD principal investigator
Hopital Européen Georges Pompidou
Peter M Pattynama, MD principal investigator
Erasmus MC Rotterdam
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sirolimus-eluting Palmaz Genesis peripheral stent in people with Renal Artery Stenosis, run by Cordis US Corp. at 3 sites in 3 countries.
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 3 inclusion and 5 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 6 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Germany, Netherlands. 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?
assessment of the angiographical in-stent minimal lumen diameter (time frame: 6-months follow up). 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 NCT00235157, 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 6 Aug 2008.