Aneurysm of Ascending Aorta, Aortic Valve Disorder, Aortic Valve Stenosis, Bicuspid Valve Disorder
Conditions
Keywords
Aorta, Aortic, Reconstruction, CABG, Bypass
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).
Interventions
DEVICEProgel Vascular Sealant
DEVICEGelfoam Plus
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment. | 5 minutes after application |
| 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 |
| Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure. | Intra-procedurally |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Progel Vascular Sealant Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Progel Vascular Sealant | 106 |
| Gelfoam Plus Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.
Gelfoam Plus | 50 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Randomized but not treated | 1 | 1 |
Baseline characteristics
| Characteristic | Progel Vascular Sealant | Gelfoam Plus | Total |
|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 14.42 | 62.4 years STANDARD_DEVIATION 14.3 | 61.8 years STANDARD_DEVIATION 14.34 |
| Region of Enrollment United States | 106 participants | 50 participants | 156 participants |
| Sex: Female, Male Female | 32 Participants | 15 Participants | 47 Participants |
| Sex: Female, Male Male | 74 Participants | 35 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 51 / 106 | 29 / 50 |
| serious Total, serious adverse events | 51 / 106 | 29 / 50 |
Outcome results
Primary
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
Population: In the Progel group one subject was not evaluable as information was not collected for the primary end-point changing the number from 106 to 105, compare to baseline characteristics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progel Vascular Sealant | 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. | 124.3 seconds | Standard Deviation 202.09 |
| Gelfoam Plus | 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. | 377.8 seconds | Standard Deviation 252.4 |
p-value: <0.0001Wilcoxon Rank-Sum Test
Secondary
Chest Tube Drainage Volume Following Surgery.
Time frame: 24 hours post procedure
Population: In the Gelfoam Plus group one subject was not evaluable as information was not collected for this endpoint, which change the number from 50 to 49, compare to baseline characteristics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progel Vascular Sealant | Chest Tube Drainage Volume Following Surgery. | 701.6 mL | Standard Deviation 499.83 |
| Gelfoam Plus | Chest Tube Drainage Volume Following Surgery. | 589.6 mL | Standard Deviation 359.41 |
Secondary
Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.
Time frame: 30 days post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Progel Vascular Sealant | Incidence of Reoperations for Aortic Bleeding Complications Following Treatment. | 0 participants |
| Gelfoam Plus | Incidence of Reoperations for Aortic Bleeding Complications Following Treatment. | 1 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Progel Vascular Sealant | Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment. | 59.4 percentage of participants |
| Gelfoam Plus | Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment. | 16.0 percentage of participants |
p-value: <0.000195% CI: [3.27, 18.11]Regression, Logistic
Secondary
Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.
Time frame: 5 minutes after application
Population: In the Progel group one subject was not evaluable as information was not collected for this endpoint, which change the number from 106 to 105, compare to baseline characteristics.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Progel Vascular Sealant | Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment. | 85.7 percentage of participants |
| Gelfoam Plus | Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment. | 40.0 percentage of participants |
p-value: <0.000195% CI: [4.07, 19.89]Regression, Logistic
Secondary
Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery
Time frame: 24 hours post procedure
Population: In the Gelfoam Plus group one subject was not evaluable as information was not collected for this endpoint, which change the number from 50 to 49, compare to baseline characteristics.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Progel Vascular Sealant | Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery | 46 participants |
| Gelfoam Plus | Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery | 19 participants |
Secondary
Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days
Time frame: 30 days post procedure
Population: One subject in Progel Vascular Sealant and one subject in Gelfoam Plus discontinue before 30days and do not have device-related SAE. They are considered as not evaluable and are not included in this analysis, thus makes the difference compared to population in baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Progel Vascular Sealant | Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days | 3 participants |
| Gelfoam Plus | Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days | 4 participants |
Secondary
Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.
Time frame: Intra-procedurally
Population: In the Vascular group two subjects were not evaluable as information was not collected for this endpoint, which changes the number from 106 to 104, compare to baseline characteristics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progel Vascular Sealant | Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure. | 59.4 minutes | Standard Deviation 30.96 |
| Gelfoam Plus | Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure. | 58.5 minutes | Standard Deviation 24.74 |