Type A Aortic Dissection Clinical Trial
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.
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.
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