Femoral Arteriotomy Closure Clinical Trial
Official title:
Pivotal Clinical Study to EvaluAte the SaFety and Effectiveness of MANTA Vascular Closure Device
Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in less than 1 minute. This may result in less blood loss and a shorter time to walking compared to alternative closure means. Use of the MANTA device in this study is experimental. All other parts of the procedure involve standard medical care.
The MANTA device is a VCD intended for use in catheterization laboratories following
percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery
access route for large bore (10‐18F ID) interventional devices. The function of MANTA is to
percutaneously close the puncture in the artery wall (arteriotomy) through which the
catheters were inserted for the procedure.
The study is being conducted to demonstrate the safety and effectiveness of MANTA in
achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous
transcatheter interventional procedures using a large-bore procedure sheath.
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