Progel Vascular Sealant

Not Applicable

Completed

• Conditions: Aortic Valve Disorder; Aortic Valve Stenosis; Aneurysm of Ascending Aorta; Bicuspid Valve Disorder
• Interventions: Device: Progel Vascular Sealant; Device: Gelfoam Plus

• Registration Number: NCT01959503
• Lead Sponsor: C. R. Bard

Brief Summary

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.

Detailed Description

The primary objective of this clinical study is to compare the time to hemostasis at the aortic anastomotic suture line in subjects receiving Progel (Test group) to that in subjects receiving Gelfoam Plus (Control group) on anastomotic suture lines involving the aortic valve, ascending aorta, or aortic arch while on cardiopulmonary bypass.

The primary endpoint of this study is the 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 (Test) or Gelfoam Plus (Control).

Study Timeline

• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-10
• Study Start: 2013-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2016-06-27
• Results First Submitted QC: 2016-11-09
• Results First Posted: 2017-01-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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. Subject is undergoing emergency surgery.
• 10. Subject is in chronic renal failure.
• 11. Subject has a hematocrit < 21% pre-operatively.
• 12. Subject has a serum creatinine ≥2.5 mg/dl at baseline or is currently on dialysis.
• 13. Subject has a cardiac ejection fraction <25%.
• 14. Subject is scheduled for another cardiac surgery within 30 days of enrollment.
• 15. Subject has an active or latent infection which is systemic or at the intended surgery site.
• 16. Subject is immuno-compromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders.
• 17. Subject is pregnant by a positive pregnancy test or has plans to become pregnant during the study period or is currently breast-feeding.
• 18. Subject is unwilling to receive blood products.
• 19. Subject has participated in another investigational research study within 30 days of enrollment.
• 20. In the opinion of the investigator, the subject has a clinical condition that would preclude the use of the study device, preclude the subject from completing the follow-up requirements, or would complicate the evaluation of this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progel Vascular Sealant	Progel Vascular Sealant	Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Gelfoam Plus	Gelfoam Plus	Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.

Primary Outcome Measures

Name	Time	Method
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.	0 seconds to 600 seconds

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.	0 seconds to 10 minutes
Chest Tube Drainage Volume Following Surgery.	24 hours post procedure
Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery	24 hours post procedure
Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.	Intra-procedurally
Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.	30 days post procedure
Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days	30 days post procedure
Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.	5 minutes after application

Trial Locations

Locations (19)

Cedars-Sinai; 🇺🇸 Los Angeles, California, United States

Ohio Health Research Institute; 🇺🇸 Columbus, Ohio, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Bryan Heart; 🇺🇸 Lincoln, Nebraska, United States

Portneuf Hospital; 🇺🇸 Pocatello, Idaho, United States

Cornell University; 🇺🇸 New York, New York, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Washington University; 🇺🇸 St. Louis, Missouri, United States

Carolinas Health Care System; 🇺🇸 Charlotte, North Carolina, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

The Heart Hospital Baylor; 🇺🇸 Plano, Texas, United States

University of Virginia Health Sciences Center; 🇺🇸 Charlottesville, Virginia, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

Virginia Commonwealth University Medical Center; 🇺🇸 Richmond, Virginia, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic Hospital; 🇺🇸 Rochester, Minnesota, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States