Myocardial Ischemia Clinical Trial
Official title:
Evaluating the Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts: The RETRIEVE Study
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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