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

CryoLife

Status

Active, not recruiting

Conditions

Type A Aortic Dissection

Treatments

Device: BioGlue Surgical Adhesive

Other: Traditional Surgical Repair

Study type

Interventional

Funder types

Industry

Identifiers

NCT03369977

BIO1601.000-C(10/16)

Details and patient eligibility

About

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.

Full 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 type A aortic dissection. The trial consists of three phases:

Phase One - A non-randomized, lead-in phase. During the lead-in phase, the first 2-3 eligible subjects at each center will receive BioGlue in open surgery. These subjects will be evaluated for safety separately from the randomized phase of the trial.

Phase Two - A randomized, controlled phase. Type A aortic dissection subjects will be randomized into TSR group (control group) and surgical repair with BioGlue group (test group) with a ratio of 1:1, so that equal number of subjects in test and control groups can be ensured.

Phase Three - A Follow-up of Late Safety Outcomes of using BioGlue in "The CHINA Trial" . Subjects enrolled in "The CHINA Trial," from both the BioGlue and the control (TSR) group, will be invited to participate. Clinical data evaluating mortality, adverse events, and re-operation rates will be collected from subject's medical charts.

Enrollment

202 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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).