This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Subject must be ≥ 18 years of age.
* 2\. Subject is scheduled for elective, primary thoracic surgery involving the aortic valve, ascending aorta, or aortic arch on cardiopulmonary bypass.
* 3\. Subject has an expected life expectancy\> 6 months.
* 4\. Subject is willing and able to comply with all aspects of the study including follow-up schedule.
* 5\. Subject or authorized representative, has the ability to provide voluntary written informed consent.
Intra-operative Inclusion Criteria:
* 1\. Subject is able to undergo an antegrade cardioplegia injection for evaluation of a leak at the aortic anastomotic site(s) during the procedure.
* 2\. Following this injection, subject has a leaking site where a topical sealant/hemostatic agent may be used to control bleeding.
Exclusion Criteria:
* 1\. Subject has Type A or other acute thoracic aortic dissection.
* 2\. Subject has undergone prior thoracic surgery (open thoracotomy not including interventional cardiology procedures).
* 3\. Subject is undergoing a planned concomitant procedure other than coronary artery bypass graft (CABG).
* 4\. Subject has a previous organ transplant.
* 5\. Subject has known or suspected preoperative coagulation disorder.
* 6\. Subject is allergic to human thrombin or has a history of allergic reactions after application of human thrombin.
* 7\. Subject is allergic to protamine.
* 8\. Subject has a Left Ventricular Assist Device (LVAD) or planned to receive an LVAD.
* 9\. S…
What they're measuring
1
Time to Achieve Hemostasis at the Aortic Anastomotic Suture Line From the Time Surgical Clamps Are Released to Cessation of Leakage at the Treated Anastomotic Site With Either Progel or Gelfoam.