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Worcester, Massachusetts 01655


A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.


Inclusion Criteria: - Male and female subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side femoral or upper extremity vascular access arterial anastomosis (e.g. femoral-femoral, femoral-popliteal, femoral-tibial, ilio-femoral, aorto-bifemoral, abdominal aortic aneurysm, upper extremity vascular access for dialysis) using uncoated or heparin-coated PTFE grafts and polypropylene sutures (size 5-0 or 6-0) with a 1:1 needle-to-thread ratio. - Following initial arterial clamp release, the study surgeon determines that adjunctive measures are needed to obtain haemostasis at the SAS. - Subjects must be willing to and capable of participating in the study, and provided written informed consent. Exclusion Criteria: - Subjects undergoing re-vascularisation using autologous conduits (e.g. saphenous vein) or prosthetic material other than uncoated or heparin-coated PTFE. - Subjects undergoing emergency surgery. - Subjects with any intra-operative findings that may preclude conduct of the study procedure. - Subjects with known intolerance to heparin, blood products or to one of the components of the study product. - Subjects unwilling to receive blood products. - Subjects with autoimmune immunodeficiency diseases (including known HIV). - Subjects who are known, current alcohol and / or drug abusers. - Subjects who have participated in another investigational drug or device research study within 30 days of enrolment. - Female subjects who are pregnant or nursing.



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Worcester, Massachusetts 01655
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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