The objective of this study is to assess the safety and effectiveness of Veriset™ Hemostatic Patch in cardiovascular procedures by comparing Veriset™ Hemostatic Patch to TachoSil® in subjects undergoing open cardiovascular surgery involving the aorta (e.g., aortic valve replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair, etc.), or CABG.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Topical hemostat
Topical Hemostat
Unnamed facility
Bonheiden, Belgium
St Luc Hospital
Brussels, Belgium
UZ Brussels
Brussels, Belgium
Unnamed facility
Genk, Belgium
Unnamed facility
Hassalt, Belgium
Unnamed facility
Leuven, Belgium
Unnamed facility
Dresden, Germany
Unnamed facility
Freiburg im Breisgau, Germany
Unnamed facility
Hamburg, Germany
Unnamed facility
Leipzig, Germany
...and 2 more locations
Time to Hemostasis (TTH)
Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).
Time frame: Day 0
Hemostasis at All Treated Bleeding Sites Within 3 Minutes
The proportion of subjects achieving hemostasis at all treated bleeding sites within 3 minutes of device application.
Time frame: Day 0
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