Progel Vascular Sealant

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01959503
Study type	Interventional
Source	C. R. Bard
Contact
Status	Completed
Phase	N/A
Start date	November 2013
Completion date	December 2014

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