Status:
UNKNOWN
Safety & Performance Study of Lumen Biomedical's FiberNet Distal Protection System for the Treatment of Renal Artery Stenosis
Lead Sponsor:
VIVA Physicians
Collaborating Sponsors:
Lumen Biomedical
Prairie Education and Research Cooperative
Conditions:
Renal Stenting in the Treatment of Pts w/a High Grade Ostial Atherosclerotic Renal Lesion(s).
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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.
- 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. -
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00674505
Start Date
January 1 2008
Last Update
February 17 2010
Active Locations (1)
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1
VIVA Physicians Inc.
San Jose, California, United States, 95123