NCT00674505

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: VIVA Physicians · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Stenting in the Treatment of Pts w/a High Grade Ostial Atherosclerotic Renal Lesion(s).

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-06-01
• First posted: 2008-05-08
• Last updated: 2010-02-17

Locations

1 site across 1 country: United States