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Progel Vascular Sealant

Primary Purpose

Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progel Vascular Sealant
Gelfoam Plus
Sponsored by
C. R. Bard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aorta, Aortic, Reconstruction, CABG, Bypass

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedars-Sinai
  • University of Colorado
  • University of Florida
  • Portneuf Hospital
  • Northwestern University
  • University of Michigan
  • Mayo Clinic Hospital
  • Washington University
  • Bryan Heart
  • Montefiore Medical Center
  • Cornell University
  • Carolinas Health Care System
  • Ohio Health Research Institute
  • University of Pennsylvania
  • Houston Methodist Hospital
  • The Heart Hospital Baylor
  • Intermountain Medical Center
  • University of Virginia Health Sciences Center
  • Virginia Commonwealth University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Progel Vascular Sealant

Gelfoam Plus

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 8, 2013
Last Updated
April 6, 2017
Sponsor
C. R. Bard
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1. Study Identification

Unique Protocol Identification Number
NCT01959503
Brief Title
Progel Vascular Sealant
Official Title
A Prospective, Randomized Study to Compare Progel Vascular Sealant to Gelfoam Plus as an Adjunct for the Control of Bleeding in Subjects Undergoing Thoracic Aortic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
Keywords
Aorta, Aortic, Reconstruction, CABG, Bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progel Vascular Sealant
Arm Type
Experimental
Arm Description
Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Arm Title
Gelfoam Plus
Arm Type
Active Comparator
Arm Description
Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Intervention Type
Device
Intervention Name(s)
Progel Vascular Sealant
Other Intervention Name(s)
Progel
Intervention Type
Device
Intervention Name(s)
Gelfoam Plus
Other Intervention Name(s)
Gelfoam
Primary Outcome Measure Information:
Title
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.
Time Frame
0 seconds to 600 seconds
Secondary Outcome Measure Information:
Title
Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.
Time Frame
5 minutes after application
Title
Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.
Time Frame
0 seconds to 10 minutes
Title
Chest Tube Drainage Volume Following Surgery.
Time Frame
24 hours post procedure
Title
Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery
Time Frame
24 hours post procedure
Title
Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.
Time Frame
Intra-procedurally
Title
Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.
Time Frame
30 days post procedure
Title
Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days
Time Frame
30 days post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Khoynezhad, MD
Organizational Affiliation
Cedars-Sinai Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Portneuf Hospital
City
Pocatello
State/Province
Idaho
ZIP/Postal Code
83201
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic Hospital
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Bryan Heart
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Carolinas Health Care System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Heart Hospital Baylor
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Virginia Health Sciences Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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Progel Vascular Sealant

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