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Active, not recruiting Not applicable

BioGlue as an Adjunct for Structural Repair and Hemostasis in Chinese Acute Type A Aortic Dissections Patients

NCT03369977 · tracked via the Priya Life Science China tracker
Sponsor
CryoLife, Inc
Phase
Not applicable
Started
2017-11-01
Last updated
2020-05-19

Condition(s) studied

Type A Aortic Dissection

Investigational drug(s) / intervention(s)

BioGlue Surgical AdhesiveTraditional Surgical Repair

BioGlue Surgical Adhesive: BioGlue (produced by CryoLife in Kennesaw, GA) is a surgical adhesive with two components respectively purified bovine serum albumin (BSA) and Glutaraldehyde (their proportions are 4:1). Crosslinked bonds (covalent bonds) of Glutaraldehyde cross-link the protein on the surface of the tissue and the amino residue of the bovine serum albumin. BioGlue also adheres to the synthetic matrix material by a mechanical interlocking mechanism in the space of graft matrix.

Traditional Surgical Repair: Traditional surgical repair as determined by the surgeon

Study 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 Chinese subject with Acute type A aortic dissections.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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).

Primary outcome measure(s)

  • Successful Closure of the False Lumen — This success can be visually confirmed intraoperatively with a TEE (binary yes/no expression for each subject)
    Successful closure of the false lumen as determined by intraoperative TEE. With successful closure of the false lumen, a complete disappearance of the false lumen will be achieved.

Trial sites (7)

FacilityCityRegionStatus
Beijing Anzhen Hospital, Capital Medical University Beijing China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School Nanjing China
Nanjing First Hospital Nanjing China
Changhai Hospital,The Second Military Medical University Shanghai China
Zhongshan Hospital, Fudan University Shanghai China
Wuhan Asia Heart Hospital Wuhan China
Henan Provincial People's Hospital Zhengzhou China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03369977 on ClinicalTrials.gov ↗ ← All trials in China