Age | Patient need for Aortic surgery Open approach | Cardiopulmonary Bypass | Informed Consent Patient Representative
Item
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
boolean
C0001779 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0877130 (UMLS CUI [2,2])
C0348025 (UMLS CUI [2,3])
C0007202 (UMLS CUI [3])
C0021430 (UMLS CUI [4,1])
C0030701 (UMLS CUI [4,2])
Informed Consent
Item
subjects must be willing to participate in the study and provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Target Bleeding Site Appropriate | Involvement Synthetic graft Aortic
Item
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;
boolean
C1521840 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C1548787 (UMLS CUI [1,4])
C1314939 (UMLS CUI [2,1])
C0185104 (UMLS CUI [2,2])
C0003483 (UMLS CUI [2,3])
Intolerance to Blood product | Intolerance to Investigational New Drugs Component | Blood product Receive Unwilling
Item
subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
boolean
C1744706 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0456388 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
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.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
female subjects who are pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Target Bleeding Site | Defects Large Arteries | Defects Large Veins | Requirement Repair Vascular Patency | EVARREST Absorbable Fibrin Sealant Patch Exposure to Blood flow
Item
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;
boolean
C1521840 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0243067 (UMLS CUI [2,1])
C0549177 (UMLS CUI [2,2])
C0003842 (UMLS CUI [2,3])
C0243067 (UMLS CUI [3,1])
C0549177 (UMLS CUI [3,2])
C0042449 (UMLS CUI [3,3])
C1514873 (UMLS CUI [4,1])
C4319951 (UMLS CUI [4,2])
C0042377 (UMLS CUI [4,3])
C4238976 (UMLS CUI [5,1])
C3896655 (UMLS CUI [5,2])
C0332157 (UMLS CUI [5,3])
C0232338 (UMLS CUI [5,4])
Target Bleeding Site | Arterial hemorrhage Major | Requirement Suture | Requirement Ligation Mechanical
Item
tbs with major arterial bleeding requiring suture or mechanical ligation;
boolean
C1521840 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0340654 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0038969 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0023690 (UMLS CUI [4,2])
C0443254 (UMLS CUI [4,3])
Target Bleeding Site | Involvement Expanded PTFE Graft
Item
tbs involves an expanded polytetrafluoroethylene (eptfe) graft
boolean
C1521840 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C1314939 (UMLS CUI [2,1])
C0015312 (UMLS CUI [2,2])
C0181074 (UMLS CUI [2,3])
Target Bleeding Site | Area Infected
Item
tbs within an actively infected field;
boolean
C1521840 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0205146 (UMLS CUI [2,1])
C0439663 (UMLS CUI [2,2])
Bleeding Site Area Bone
Item
bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
boolean
C0019080 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C0262950 (UMLS CUI [1,4])
Finding Intraoperative Excludes Completion of clinical trial
Item
subjects with any intra-operative findings identified by the investigator that may preclude conduct of the study procedure;
boolean
C0243095 (UMLS CUI [1,1])
C0456904 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])