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A Premarket, Prospective, Randomized, Single-Blind Study to Compare the Veriset™ Hemostatic Patch to TachoSil® as an Adjunct to Hemostasis in Subjects Undergoing Cardiovascular Surgery

NCT01639833 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2014-07-03

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

Veriset Hemostatic Patch

Topical hemostat

DEVICE

TachoSil®

Topical Hemostat

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • David Glineur, MD · Clinique St-Luc Bouge, Namur, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Belgium
  • Germany
  • Latvia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01639833 on ClinicalTrials.gov