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Sponsors and Collaborators: |
VIVA Physicians Lumen Biomedical Prairie Education and Research Cooperative |
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Information provided by: | VIVA Physicians |
ClinicalTrials.gov Identifier: | NCT00674505 |
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.
Condition | Intervention |
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Renal Stenting in the Treatment of Pts w/a High Grade Ostial Atherosclerotic Renal Lesion(s). |
Device: Lumen Biomedical FiberNet Embolic Protection System |
Study Type: | Interventional |
Study Design: | Open Label, Single Group Assignment, Safety/Efficacy 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 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Treatment, Open label, Single Group Assignment |
Device: Lumen Biomedical FiberNet Embolic Protection System
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).
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Unilateral or bilateral atherosclerotic de novo renal artery stenosis (RAS) associated with any or all of the following:
Angiographic Inclusion Criteria
Exclusion Criteria:
Clinical Exclusion Criteria
Angiographic Exclusion Criteria
United States, California | |
VIVA Physicians Inc. | Recruiting |
San Jose, California, United States, 95123 | |
Contact: John Laird, MD 408-513-3240 jlaird@vivapvd.com | |
Contact: Rebecca Hall 408-513-3241 rhall@vivapvd.com | |
Sub-Investigator: Jim Joye, DO |
Responsible Party: | University of California, Davis ( John R. Laird, MD ) |
Study ID Numbers: | G070189/S002 |
Study First Received: | May 6, 2008 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00674505 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Arterial Occlusive Diseases Urologic Diseases Embolism Vascular Diseases |
Renal Artery Stenosis Constriction, Pathologic Kidney Diseases Renal Artery Obstruction |
Arterial Occlusive Diseases Urologic Diseases Vascular Diseases |
Cardiovascular Diseases Kidney Diseases Renal Artery Obstruction |