Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ethicon, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass. Subjects in Japan between ≥18 and \<20 years of age will require consent by the subject's legal representative
Subjects must be willing to participate in the study and provide written informed consent.
Presence of an appropriate Target Bleeding Site (TBS) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator;
You may not be if
Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 60 day follow up period after surgery.
Female subjects who are pregnant or nursing.
TBS is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ Fibrin Sealant Patch to blood flow and/or pressure during absorption of the product;
TBS with major arterial bleeding requiring suture or mechanical ligation;
TBS involves an expanded polytetrafluoroethylene (ePTFE) graft
TBS within an actively infected field;
Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
Subjects with any intra-operative findings identified by the investigator that may preclude conduct of the study procedure;
