Renal Stenting in the Treatment of Pts w/a High Grade Ostial Atherosclerotic Renal Lesion(s).FORTRESSNCT00674505
Safety & Performance Study of Lumen Biomedical's FiberNet Distal Protection System for the Treatment of Renal Artery Stenosis
A study testing Lumen Biomedical FiberNet Embolic Protection System in people with Renal Stenting in the Treatment of Pts w/a High Grade Ostial Atherosclerotic Renal Lesion(s)., run by VIVA Physicians at 1 site in United States.
Trial summary
To evaluate the procedural safety and filter efficiency of the FiberNet® Embolic Protection System when used in conjunction with the Boston Scientific Express SD Stent System for primary stenting of ostial atherosclerotic renal lesions in patients with atherosclerotic renal artery stenosis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Renal Stenting in the Treatment of Pts w/a High Grade Ostial Atherosclerotic Renal Lesion(s).
- What is being tested?
- Lumen Biomedical FiberNet Embolic Protection System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2009
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 85 years.
- Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed an IRB approved consent form.
- Subject understands the duration of the study and it's follow up visit requirements.
- Unilateral or bilateral atherosclerotic de novo renal artery stenosis (RAS) associated with any or all of the following:
- SBP >140 despite ≥3 anti-hypertensive medications
- Estimated Glomerular Filtration Rate (eGFR) ≥30-≤70 cc/min calculated using the Modified Diet in Renal Disease (MDRD) formula
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- Recurrent episodes of decompensated heart failure
- Recurrent episodes of "flash" pulmonary edema
- Angiographic Inclusion Criteria
- ≥70% <100% renal artery stenosis (by visual estimate) involving unilateral, bilateral renal arteries or solitary renal artery.
- Renal pole-to-pole length >7cm.
- Lesion ≤15 mm from the aorto-ostial junction.
- Renal artery reference lumen diameter ≥3.5 - ≤7 mm for FiberNet placement.
Who cannot join
- Clinical Exclusion Criteria
- Estimated life expectancy <12 months.
- Estimated Glomerular Filtration Rate (eGFR) <30 cc/min.
- Renal pole-to-pole length <7cm on side of diseased kidney.
- No history of transplanted kidneys or polycystic kidney disease.
- Uncontrolled hypercoagulability.
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- Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies, nitinol and stainless steel.
- Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
- Patient refuses possible temporary or permanent hemodialysis.
- Refuses possible surgery for repair of access site or renal artery.
- Known severe coronary or carotid disease likely to require surgical treatment after enrollment or during follow-up period.
- Uncompensated congestive heart failure.
- Current enrollment in any investigational study wherein patient participation has not been completed.
- Cardiovascular surgical or cardiovascular interventional procedures (including, but not limited to, aortic, renal, cardiac, carotid, femoro-popliteal, and below the knee) within 30 days prior to enrollment in this study.
- Planned or predicted cardiovascular surgical or interventional procedures outside of the affected renal artery (including, but not limited to, aortic, renal, cardiac, carotid, contralateral femoro-popliteal, and contralateral below the knee) within 30 days after entry into this study and prior to completion of the 30 day follow-up.
- Pregnancy, breast-feeding or plans to become pregnant in female of child bearing potential.
- Any patient who in the opinion of the investigator would not be a good candidate for enrollment.
- Angiographic Exclusion Criteria
- Early bifurcation of the main renal artery preventing complete embolic protection of the kidney with the FiberNet.
- Fibromuscular Dysplasia.
- Presence of thrombus at the lesion site.
- Non-ostial atherosclerosis (lesion >15mm from the renal ostium).
- Subintimal guidewire placement resulting in dissection of the renal artery or aorta, or perforation of the renal artery or aorta prior to deployment of the device.
- Severe calcification likely to prevent the passage of the device. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FiberNet Renal Artery Embolic Protection Study: A Prospective, Single-arm Feasibility Trial of Renal Artery Distal Protection Using the Lumen Biomedical FiberNet Embolic Protection System
To evaluate the procedural safety and filter efficiency of the FiberNet® Embolic Protection System when used in conjunction with the Boston Scientific Express SD Stent System for primary stenting of ostial atherosclerotic renal lesions in patients with atherosclerotic renal artery stenosis.
- Conditions
- Renal Stenting in the Treatment of Pts w/a High Grade Ostial Atherosclerotic Renal Lesion(s).
- Being tested
- Lumen Biomedical FiberNet Embolic Protection System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumen Biomedical FiberNet Embolic Protection SystemDevice
to demonstrate the safety and filter efficiency of the Lumen Biomedical FiberNet Embolic Protection System during the performance of primary renal stenting in the treatment of pts with a high grade ostial atherosclerotic renal lesion(s).
| Study group | Role | What they receive |
|---|---|---|
| Treatment, Open label, Single Group Assignment | Other | Not described Receives: Device: Lumen Biomedical FiberNet Embolic Protection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurable amount of macro/micro atheroma particle captured by the FiberNet EPS as adjudicated by core lab analysis.
Measured: Various secondary endpoints evaluated at 30 days and 6 months
Secondary outcomes (1)
Progression to temporary/permanent renal replacement therapy and Analysis of debris captured by the FiberNet® Embolic Protection System
Measured: most at 30 days and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2009 (estimated)
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 Stenting in the Treatment of Pts w/a High Grade Ostial Atherosclerotic Renal Lesion(s).Studies 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVA Physicians
- Sponsor type
- University, hospital or other
- Collaborators
- Lumen Biomedical, Prairie Education and Research Cooperative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674505
- Sponsor's protocol ID
- G070189/S002
- Acronym
- FORTRESS
- Status last verified
- Feb 2010
- First submitted
- 6 May 2008
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Laird JR, Tehrani F, Soukas P, Joye JD, Ansel GM, Rocha-Singh K. Feasibility of FiberNet(R) embolic protection system in patients undergoing angioplasty for atherosclerotic renal artery stenosis. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):430-6. doi: 10.1002/ccd.23292. Epub 2011 Dec 8.
PubMed 21805607
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FiberNet Renal Artery Embolic Protection Study: A Prospective, Single-arm Feasibility Trial of Renal Artery Distal Protection Using the Lumen Biomedical FiberNet Embolic Protection System
- ClinicalTrials.gov ID
- NCT00674505
- Acronym / sponsor ID
- FORTRESS / G070189/S002
- Conditions
- Renal Stenting in the Treatment of Pts w/a High Grade Ostial Atherosclerotic Renal Lesion(s).
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VIVA PhysiciansUniversity, hospital or other
- Collaborators
- Lumen Biomedical, Prairie Education and Research Cooperative
- Study start
- Jan 2008
- Primary completion
- Jun 2009 (estimated)
- First posted
- 8 May 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.
To evaluate the procedural safety and filter efficiency of the FiberNet® Embolic Protection System when used in conjunction with the Boston Scientific Express SD Stent System for primary stenting of ostial atherosclerotic renal lesions in patients with atherosclerotic renal artery stenosis.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment, Open label, Single Group Assignment | Other | Device: Lumen Biomedical FiberNet Embolic Protection System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 and ≤ 85 years.
- Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed an IRB approved consent form.
- Subject understands the duration of the study and it's follow up visit requirements.
- Unilateral or bilateral atherosclerotic de novo renal artery stenosis (RAS) associated with any or all of the following:
- Angiographic Inclusion Criteria
Key exclusion criteria (24 listed)
- Clinical Exclusion Criteria
- Estimated life expectancy <12 months.
- Estimated Glomerular Filtration Rate (eGFR) <30 cc/min.
- Renal pole-to-pole length <7cm on side of diseased kidney.
- No history of transplanted kidneys or polycystic kidney disease.
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 |
|---|---|---|
| Lumen Biomedical FiberNet Embolic Protection Systemto demonstrate the safety and filter efficiency of the Lumen Biomedical FiberNet Embolic Protection System during the performance of primary renal stenting in the treatment of pts with a high grade ostial atherosclerotic renal lesion(s). | Device | Treatment, Open label, Single Group Assignment |
Primary outcome
Measurable amount of macro/micro atheroma particle captured by the FiberNet EPS as adjudicated by core lab analysis.
Time frame: Various secondary endpoints evaluated at 30 days and 6 months
1 secondary outcome
Progression to temporary/permanent renal replacement therapy and Analysis of debris captured by the FiberNet® Embolic Protection System
Time frame: most at 30 days and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2010.
- Derived from this study: PubMed 21805607Laird JR, Tehrani F, Soukas P, Joye JD, Ansel GM, Rocha-Singh K. Feasibility of FiberNet(R) embolic protection system in patients undergoing angioplasty for atherosclerotic renal artery stenosis. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):430-6. doi: 10.1002/ccd.23292. Epub 2011 Dec 8.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumen Biomedical FiberNet Embolic Protection System in people with Renal Stenting in the Treatment of Pts w/a High Grade Ostial Atherosclerotic Renal Lesion(s)., run by VIVA Physicians 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 13 inclusion and 24 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 17 Feb 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 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.
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?
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?
Measurable amount of macro/micro atheroma particle captured by the FiberNet EPS as adjudicated by core lab analysis. (time frame: Various secondary endpoints evaluated at 30 days and 6 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 NCT00674505, 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 17 Feb 2010; AzTrials last refreshed its copy on 8 Nov 2026.