The Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter Removal Clinical Trial
Official title:
Clinical Evaluation of Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable Vascular Access Closure System and Perclose® ProGlide Suture-Mediated Closure System; Randomized, Comparative Study
It is purposed to verify a superiority of the Fastseal® Bioabsorbable Vascular Access Closure System through effectiveness and safety confirmation of hemostasis (TTH; Time to hemstasis) and ambulation (TTA; Time to ambulation) at the puncture site of common femoral artery (CFA) after the procedures of Fastseal® Biosorbable Vascular Access Closure System or Perclose® ProGlide Suture-Mediated Closure System during 1 month observation.
Prospective, Single blind, randomized
Comparative study using the Fastseal® Bioabsorbable Vascular Access Closure System as an
investigational device and the Perclose® ProGlide Suture-Mediated Closure System as a
comparator.
After going through the confirmation of inclusion/exclusion criteria with signed subjects,
they will have a procedure either of the two devices. The subjects should follow designated
physician's instructions accurately during the clinical trial period.There are about 6 times
evaluations Including screening.
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