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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.