Status:
ACTIVE_NOT_RECRUITING
BioGlue as an Adjunct for Structural Repair and Hemostasis in Chinese Acute Type A Aortic Dissections Patients
Lead Sponsor:
CryoLife, Inc.
Conditions:
Type A Aortic Dissection
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
A multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of BioGlue as an adjunct for structural repair and hemostasis to traditional surgical repair in...
Detailed Description
A multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of BioGlue as an adjunct for structural repair and hemostasis in Chinese subjects with acute ty...
Eligibility Criteria
Inclusion
- Male or female subjects 18-70 years of age.
- Subject has a confirmed diagnosis of acute type A aortic dissection with subtype A2.
- Subject is willing and able to give written consent for the trial. If the subject is unconscious or under the influence of medications which render him or her unable to give fully informed consent, a guardian may provide informed consent for the subject regarding trial participation.
Exclusion
- Subjects with known allergy to albumin, bovine products, or glutaraldehyde.
- Subjects who have been treated with an investigational product who have not completed the entire follow-up period.
- Subjects who do not meet the eligibility criteria, including those who do not wish to participate or give informed consent for trial participation, will not be enrolled into the trial, and will be offered equivalent, non-trial surgical or other treatment, as judged appropriate by the investigator.
- Subjects with previous cardiac and aortic surgery.
- End stage malperfusion syndromes (i.e. end-organ failure such as coma, paraplegia, hemiplegia, intestinal necrosis, or hepatic failure).
- Subjects with Marfan syndrome or other connective tissue disorders.
- Previous chronic dissections resulting from non-cardiac surgery and/or trauma.
- Concomitant surgery of valve replacement (both in screening and intraoperative).
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT03369977
Start Date
November 1 2017
End Date
November 1 2020
Last Update
May 19 2020
Active Locations (7)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
2
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
3
Nanjing First Hospital
Nanjing, China
4
Changhai Hospital,The Second Military Medical University
Shanghai, China