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

NCT03369977 | Active Not Recruiting FDA Device

• 1 other identifier: BIO1601.000-C(10/16)
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 7

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 Chinese subject with Acute type A aortic dissections.

Conditions

Type A Aortic Dissection

Keywords

BioGlue Surgical Adhesive; Type A Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• Successful Closure of the False Lumen

  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.

  This success can be visually confirmed intraoperatively with a TEE (binary yes/no expression for each subject)

Secondary Outcomes (5)

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

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

• Time to repair the sinuses of Valsalva

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

• Evaluate the successful hemostasis at the anastomotic site

  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.

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

  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)

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

  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).

Study Arms (2)

BioGlue Surgical Adhesive

EXPERIMENTAL

Subjects in the BioGlue group will receive BioGlue as an adjunct for traditional surgical repair of the sinus of Valsalva.

Device: BioGlue Surgical Adhesive

Traditional Surgical Repair

OTHER

Subjects in the control group will receive traditional surgical repair of the sinus of Valsalva.

Other: Traditional Surgical Repair

Interventions

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.

BioGlue Surgical Adhesive

Traditional Surgical Repair OTHER

Traditional surgical repair as determined by the surgeon

Traditional Surgical Repair

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CryoLife, Inc.: lead

Study Sites (7)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

Nanjing, China

Location

Nanjing First Hospital

Nanjing, China

Location

Changhai Hospital,The Second Military Medical University

Shanghai, China

Location

Zhongshan Hospital, Fudan University

Shanghai, China

Location

Wuhan Asia Heart Hospital

Wuhan, China

Location

Henan Provincial People's Hospital

Zhengzhou, China

Location

Study Officials

• Scott B Capps, MS

  CryoLife, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 12, 2017
• Study Start: November 1, 2017
• Primary Completion: June 24, 2018
• Study Completion: November 1, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

CN (7)