Safety & Performance Study of Lumen Biomedical's FiberNet Distal Protection System for the Treatm… (NCT00674505) | Clinical Trial Compass
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Safety & Performance Study of Lumen Biomedical's FiberNet Distal Protection System for the Treatment of Renal Artery Stenosis
United States20 participantsStarted 2008-01
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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: