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

2014-08-27 03:30:46 | BioPortfolio

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Conditions

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

Intervention

Lumen Biomedical FiberNet Embolic Protection System

Location

VIVA Physicians Inc.
San Jose
California
United States
95123

Status

Active, not recruiting

Source

VIVA Physicians

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:30:46-0400

Clinical Trials [1711 Associated Clinical Trials listed on BioPortfolio]

EPIC European Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting

Multicenter, prospective, study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet Embolic Protection System as an adjunctive device during carotid a...

EPIC US Feasibility Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting

Multicenter, prospective, feasibility study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive device d...

The RETRIEVE Study: Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts

This is a multicenter, prospective study designed to demonstrate the performance and safety of the FiberNet Embolic Protection System when used as an adjunctive device during saphenous vei...

Carotid Stenting vs. Surgery of Severe Carotid Artery Disease and Stroke Prevention in Asymptomatic Patients (ACT I)

The study is being conducted to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield® Embolic Protection System and Emboshield® Pro Embolic Protection Sy...

Safety and Efficacy of Distal Embolic Protection Device in Vertebral Artery Origin Stenting

This is a prospective single-center,randomized controlled trial,aiming to investigate the safety and efficacy of distal EPD in vertebral artery origin stenting(VAOS);256 subjects will be r...

PubMed Articles [15168 Associated PubMed Articles listed on BioPortfolio]

Incidence of urinary extravasation and rate of ureteral stenting after high-grade renal trauma in adults: a meta-analysis.

Collecting system injury and urinary extravasation is an important yet understudied aspect of renal trauma. We aimed to examine the incidence of urinary extravasation and also the rates of ureteral st...

Renal artery stenting for atherosclerotic renal artery stenosis identified in patients with coronary artery disease: Does captopril renal scintigraphy predict outcomes?

The authors evaluated the effectiveness of percutaneous renal revascularization (PRR) with stenting for the treatment of atherosclerotic renal artery stenosis (ARAS) in patients with coronary artery d...

Robotic-Assisted Percutaneous Coronary Intervention of a Saphenous Vein Graft Stenosis using a FilterWire EZ Embolic Protection.

Robotic-assisted coronary angioplasty has been utilized to decrease radiation exposure to cardiologists, and to diminish risk of orthopedic and ergonomic injuries caused by wearing heavy lead during l...

Predictors of antegrade flow at internal carotid artery during carotid artery stenting with proximal protection.

Carotid artery stenting (CAS) with proximal occlusion effectively prevent distal cerebral embolism by flow arrest at internal carotid artery (ICA); however, the method can expose antegrade flow at ICA...

Design and performance evaluation of collision protection-based safety operation for a haptic robot-assisted catheter operating system.

The robot-assisted catheter system can increase operating distance thus preventing the exposure radiation of the surgeon to X-ray for endovascular catheterization. However, few designs have considered...

Medical and Biotech [MESH] Definitions

Vascular filters or occlusive devices that provide mechanical protection of the distal end organ from blood clots or EMBOLISM-causing debri dislodged during ENDOVASCULAR PROCEDURES.

Brief reversible episodes of focal, nonconvulsive ischemic dysfunction of the brain having a duration of less than 24 hours, and usually less than one hour, caused by transient thrombotic or embolic blood vessel occlusion or stenosis. Events may be classified by arterial distribution, temporal pattern, or etiology (e.g., embolic vs. thrombotic). (From Adams et al., Principles of Neurology, 6th ed, pp814-6)

The internal portion of the kidney, consisting of striated conical masses, the renal pyramids, whose bases are adjacent to the cortex and whose apices form prominent papillae projecting into the lumen of the minor calyces.

An encapsulated accumulation of URINE in the retroperitoneal area. It has the appearance of a cyst (CYSTS). Urinoma is usually caused by URETERAL OBSTRUCTION, renal trauma or perforation of the renal collecting system.

A nongenetic defect due to malformation of the KIDNEY which appears as a bunch of grapes with multiple renal cysts but lacking the normal renal bean shape, and the collection drainage system. This condition can be detected in-utero with ULTRASONOGRAPHY.

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