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San Jose, California 95123


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.


Inclusion Criteria: 1. Age ≥ 18 and ≤ 85 years. 2. 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. 3. Subject understands the duration of the study and it's follow up visit requirements. 4. Unilateral or bilateral atherosclerotic de novo renal artery stenosis (RAS) associated with any or all of the following: 1. SBP >140 despite ≥3 anti-hypertensive medications 2. Estimated Glomerular Filtration Rate (eGFR) ≥30-≤70 cc/min calculated using the Modified Diet in Renal Disease (MDRD) formula 3. Recurrent episodes of decompensated heart failure 4. Recurrent episodes of "flash" pulmonary edema Angiographic Inclusion Criteria 1. ≥70% <100% renal artery stenosis (by visual estimate) involving unilateral, bilateral renal arteries or solitary renal artery. 2. Renal pole-to-pole length >7cm. 3. Lesion ≤15 mm from the aorto-ostial junction. 4. Renal artery reference lumen diameter ≥3.5 - ≤7 mm for FiberNet placement. Exclusion Criteria: Clinical Exclusion Criteria 1. Estimated life expectancy <12 months. 2. Estimated Glomerular Filtration Rate (eGFR) <30 cc/min. 3. Renal pole-to-pole length <7cm on side of diseased kidney. 4. No history of transplanted kidneys or polycystic kidney disease. 5. Uncontrolled hypercoagulability. 6. Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies, nitinol and stainless steel. 7. Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure. 8. Patient refuses possible temporary or permanent hemodialysis. 9. Refuses possible surgery for repair of access site or renal artery. 10. Known severe coronary or carotid disease likely to require surgical treatment after enrollment or during follow-up period. 11. Uncompensated congestive heart failure. 12. Current enrollment in any investigational study wherein patient participation has not been completed. 13. 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. 14. 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. 15. Pregnancy, breast-feeding or plans to become pregnant in female of child bearing potential. 16. Any patient who in the opinion of the investigator would not be a good candidate for enrollment. Angiographic Exclusion Criteria 1. Early bifurcation of the main renal artery preventing complete embolic protection of the kidney with the FiberNet. 2. Fibromuscular Dysplasia. 3. Presence of thrombus at the lesion site. 4. Non-ostial atherosclerosis (lesion >15mm from the renal ostium). 5. 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. 6. Severe calcification likely to prevent the passage of the device. -

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:


Brief Title:

Safety & Performance Study of Lumen Biomedical's FiberNet Distal Protection System for the Treatment of Renal Artery Stenosis

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

Overall Status:

Active, not recruiting

Study Phase:




Minimum Age:

18 Years

Maximum Age:

85 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

VIVA Physicians

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Endpoint Classification: Safety/Efficacy Study, I

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Study Dates

Start Date:January 2008
Primary Completion Date:June 2009
Primary Completion Type:Anticipated
Verification Date:February 2010
Last Changed Date:February 16, 2010
First Received Date:May 6, 2008

Study Outcomes

Outcome Type: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
Safety Issues:True
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True

Study Interventions

Intervention Type:Device
Name:Lumen Biomedical FiberNet Embolic Protection Syste
Description: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).
Arm Name:Treatment, Open label, Single Group Assignment

Study Arms

Study Arm Type:Other
Arm Name:Treatment, Open label, Single Group Assignment

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:VIVA Physicians
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Lumen Biomedical

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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