Progel Vascular Sealant

NCT ID: NCT01959503

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-12-31

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).

Conditions

Aortic Valve Stenosis; Aneurysm of Ascending Aorta; Aortic Valve Disorder; Bicuspid Valve Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Progel Vascular Sealant

Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.

Group Type: EXPERIMENTAL

Progel Vascular Sealant

Intervention Type: DEVICE

Gelfoam Plus

Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.

Group Type: ACTIVE_COMPARATOR

Gelfoam Plus

Intervention Type: DEVICE

Interventions

Progel Vascular Sealant

Intervention Type: DEVICE

Gelfoam Plus

Intervention Type: DEVICE

Other Intervention Names

Progel; Gelfoam

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Khoynezhad, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Heart Institute

Locations

Cedars-Sinai

Los Angeles, California, United States

University of Colorado

Aurora, Colorado, United States

University of Florida

Gainesville, Florida, United States

Portneuf Hospital

Pocatello, Idaho, United States

Northwestern University

Chicago, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic Hospital

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Bryan Heart

Lincoln, Nebraska, United States

Cornell University

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Carolinas Health Care System

Charlotte, North Carolina, United States

Ohio Health Research Institute

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Houston Methodist Hospital

Houston, Texas, United States

The Heart Hospital Baylor

Plano, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Virginia Health Sciences Center

Charlottesville, Virginia, United States

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Countries

United States

References

Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.

Reference Type: DERIVED

PMID: 38695613 (View on PubMed)

Other Identifiers

NEO13-100

Identifier Type: -

Identifier Source: org_study_id