Aortic Valve Stenosis Clinical Trial
Official title:
A Prospective, Randomized Study to Compare Progel Vascular Sealant to Gelfoam Plus as an Adjunct for the Control of Bleeding in Subjects Undergoing Thoracic Aortic Surgery
This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
The primary objective of this clinical study is to compare the time to hemostasis at the
aortic anastomotic suture line in subjects receiving Progel (Test group) to that in subjects
receiving Gelfoam Plus (Control group) on anastomotic suture lines involving the aortic
valve, ascending aorta, or aortic arch while on cardiopulmonary bypass.
The primary endpoint of this study is the time to achieve hemostasis at the aortic
anastomotic suture line from the time surgical clamps are released to cessation of leakage
at the treated anastomotic site with either Progel (Test) or Gelfoam Plus (Control).
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