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

Myocardial Ischemia Clinical Trial

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

Clinical Trial Summary

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 vein graft (SVG) intervention.

Clinical Trial Description

The study will involve up to 30 patients to be enrolled using the FiberNet device during clinically indicated percutaneous intervention of SVG and followed through 30 days post procedure. Patients will be enrolled at up to 10 Investigative Sites. The study is a prospective multi-center registry with sequential enrollment of qualified patients who consent to participate and meet all entrance criteria.

The Lumen Biomedical, Inc. FiberNet® Embolic Protection System is indicated for use as a guide wire and embolic protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in saphenous vein grafts with reference vessel diameters of 1.75 mm to 7.0 mm. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00453518
Study type Interventional
Source Lumen Biomedical
Contact
Status Completed
Phase N/A
Start date March 2007
Completion date February 2009
View Details
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