Clinical trial NCT03369977: BioGlue as an Adjunct for Structural Repair and Hemostasis in Chinese Acute Type A Aortic Dissections Patients
Official 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type A Aortic Dissection
Keywords: BioGlue Surgical Adhesive
Type A Aortic Dissection
Lead sponsor: CryoLife
Sponsor class: UNKNOWN
First posted: 2017-12-12
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Successful Closure of the False Lumen
timeFrame: This success can be visually confirmed intraoperatively with a TEE (binary yes/no expression for each subject)
Secondary outcomes:
measure: Successful closure of the false lumen by CTA or TTE at discharge
timeFrame: CTA or TTE scan at discharge or at 20 days (+/- 10 days) post-operatively for subjects with longer hospital stays.
measure: Time to repair the sinuses of Valsalva
timeFrame: The time for repairing the sinuses of Valsalva will be documented intraoperatively.
measure: Evaluate the successful hemostasis at the anastomotic site
timeFrame: 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.
measure: Treatment failure of the aortic dissection repair site identified in "The CHINA Trial" which leads to either post-discharge mortality or re-operation.
timeFrame: 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)
measure: Proportion of subjects with device-related or procedure-related adverse events, determined by the investigators.
timeFrame: 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).
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
city: Nanjing
country: China
facility: Nanjing First Hospital
city: Shanghai
country: China
facility: Changhai Hospital,The Second Military Medical University
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
Study officials:
affiliation: CryoLife, Inc.
name: Scott B Capps, MS
role: STUDY_DIRECTOR
References: