An interventional study of BioGlue Surgical Adhesive and Traditional Surgical Repair in Type A Aortic Dissection, sponsored by CryoLife, Inc.. Active, not recruiting at 7 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-05-19.
Sponsored by CryoLife, Inc. · Not applicable, Interventional, and Treatment
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.
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.
CryoLife, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in the BioGlue group will receive BioGlue as an adjunct for traditional surgical repair of the sinus of Valsalva.
Device: BioGlue Surgical Adhesive
Subjects in the control group will receive traditional surgical repair of the sinus of Valsalva.
Other: Traditional Surgical Repair
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 as determined by the surgeon
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.
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 by CTA or TTE at discharge
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.
Time frame: 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
During the operation the time to repair the sinuses of Valsalva will be recorded.
Time frame: The time for repairing the sinuses of Valsalva will be documented intraoperatively.
Evaluate the successful hemostasis at the anastomotic site
Hemostasis is assessed visually (i.e. lack of any observable extravascular bleeding) and is monitored until hemostasis is achieved at each applied 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.
Treatment failure of the aortic dissection repair site identified in "The CHINA Trial" which leads to either post-discharge mortality or re-operation.
Post-operative mortality and re-operation(s) will be collected from the subjects' medical charts retrospectively and during informed consent telephone notification.
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)
Proportion of subjects with device-related or procedure-related adverse events, determined by the investigators.
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).
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).
Ran from Nov 2017 to primary completion in Jun 2018, 7 months.
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This study is active, not recruiting, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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CryoLife, Inc.