NCT01959503

Progel Vascular Sealant

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Aortic Valve Stenosis
• Aneurysm of Ascending Aorta
• Aortic Valve Disorder
• Bicuspid Valve Disorder

Interventions

Type	Name	Description
DEVICE	Progel Vascular Sealant
DEVICE	Gelfoam Plus

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-10-10
• Last updated: 2017-04-10
• Results posted: 2017-01-09

Locations

19 sites across 1 country: United States