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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
The FiberNet EPS is indicated for use as a guide wire and embolic protection system to capture and remove embolic material produced while performing percutaneous transluminal interventional procedures in saphenous vein grafts.
Munroe Regional Medical Center
Ocala, Florida, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Christ Hospital
Cincinnati, Ohio, United States
The primary objective of the study is to evaluate the safety and performance of the FiberNet Embolic Protection System. The primary endpoint is major adverse cardiac events (MACE) rate at 30 days.
Time frame: 30 days
The secondary study objectives are endpoints related to the use of the FiberNet system and additional safety endpoints.
Time frame: index hospitalization
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Riverside Methodist Hospital
Columbus, Ohio, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States