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

NCT ID: NCT03369977

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2020-11-30

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.

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 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.

Conditions

Type A Aortic Dissection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BioGlue Surgical Adhesive

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

Group Type: EXPERIMENTAL

BioGlue Surgical Adhesive

Intervention Type: 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

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

Group Type: OTHER

Traditional Surgical Repair

Intervention Type: OTHER

Traditional surgical repair as determined by the surgeon

Interventions

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.

Intervention Type: DEVICE

Traditional Surgical Repair

Traditional surgical repair as determined by the surgeon

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CryoLife, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott B Capps, MS

Role: STUDY_DIRECTOR

CryoLife, Inc.

Locations

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

Countries

China

Other Identifiers

BIO1601.000-C(10/16)

Identifier Type: -

Identifier Source: org_study_id