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NCT Number: NCT03369977

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

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.

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Key information

Conditions

Type A Aortic Dissection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital, Capital Medical University, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

BioGlue Surgical Adhesive

Device

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

Other

Traditional surgical repair as determined by the surgeon

Primary outcomes

  1. Successful Closure of the False Lumen

    Time frame: 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.

Secondary outcomes

  1. Successful closure of the false lumen by CTA or TTE at discharge

    Time frame: CTA or TTE scan at discharge or at 20 days (+/- 10 days) post-operatively for subjects with longer hospital stays.

    Successful closure of the false lumen at discharge or at 20 days (+/- 10 days) post-operatively confirmed by CTA scan or Transthoracic Echocardiogram (TTE) scan if the subject is unable to have a CTA.

  2. Time to repair the sinuses of Valsalva

    Time frame: The time for repairing the sinuses of Valsalva will be documented intraoperatively.

    During the operation the time to repair the sinuses of Valsalva will be recorded.

  3. Evaluate the successful hemostasis at the anastomotic site

    Time frame: The measurement begins intraoperatively after either BioGlue or Traditional Surgical Repair is applied to the anastomotic suture line(s) and the bypass cross clamp is released.

    Hemostasis is assessed visually (i.e. lack of any observable extravascular bleeding) and is monitored until hemostasis is achieved at each applied anastomotic site.

  4. Treatment failure of the aortic dissection repair site identified in "The CHINA Trial" which leads to either post-discharge mortality or re-operation.

    Time frame: The measurement begins at discharge and will end when the retrospective chart review is performed by the hospital (could be up to 3 years post-op)

    Post-operative mortality and re-operation(s) will be collected from the subjects' medical charts retrospectively and during informed consent telephone notification.

  5. Proportion of subjects with device-related or procedure-related adverse events, determined by the investigators.

    Time frame: The measurement begins at discharge and will end when the retrospective chart review is performed by the hospital (could be up to 3 years post-op).

    Post-operative adverse event(s) will be collected from the subjects' medical charts retrospectively. Assessment will only be performed on the surgical site from "The CHINA Trial," defined as obliteration of the false lumen (BioGlue group) or repair of acute type A aortic dissection (control group) and anastomosis (both BioGlue and control groups).

Sponsors and collaborators

Lead sponsor

CryoLife, Inc.

Industry

Registry information

Official study title

Multi-center, Randomized, Controlled Clinical Trial of BioGlue Surgical Adhesive as an Adjunct for Structural Repair and Hemostasis in Chinese Patients With Acute Type A Aortic Dissections.

Acronym: CHINA

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Dec 12, 2017
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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