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CompletedNCT01959503Updated Apr 10, 2017Results posted

Progel Vascular Sealant

An interventional study of Progel Vascular Sealant and Gelfoam Plus in Aortic Valve Stenosis, Aneurysm of Ascending Aorta and Aortic Valve Disorder, sponsored by C. R. Bard. Completed at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-10.

Sponsored by C. R. Bard · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

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

Keywords

  • Aorta
  • Aortic
  • Reconstruction
  • CABG
  • Bypass
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 158 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

C. R. Bard is the lead sponsor of 113 studies on the registry; 6 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Subject must be ≥ 18 years of age.
    1. Subject is scheduled for elective, primary thoracic surgery involving the aortic valve, ascending aorta, or aortic arch on cardiopulmonary bypass.
    1. Subject has an expected life expectancy> 6 months.
    1. Subject is willing and able to comply with all aspects of the study including follow-up schedule.
    1. 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.
    1. Following this injection, subject has a leaking site where a topical sealant/hemostatic agent may be used to control bleeding.

Exclusion criteria

Exclusion Criteria:

    1. Subject has Type A or other acute thoracic aortic dissection.
    1. Subject has undergone prior thoracic surgery (open thoracotomy not including interventional cardiology procedures).
    1. Subject is undergoing a planned concomitant procedure other than coronary artery bypass graft (CABG).
    1. Subject has a previous organ transplant.
    1. Subject has known or suspected preoperative coagulation disorder.
    1. Subject is allergic to human thrombin or has a history of allergic reactions after application of human thrombin.
    1. Subject is allergic to protamine.
    1. Subject has a Left Ventricular Assist Device (LVAD) or planned to receive an LVAD.
    1. Subject is undergoing emergency surgery.
    1. Subject is in chronic renal failure.
    1. Subject has a hematocrit \< 21% pre-operatively.
    1. Subject has a serum creatinine ≥2.5 mg/dl at baseline or is currently on dialysis.
    1. Subject has a cardiac ejection fraction \<25%.
    1. Subject is scheduled for another cardiac surgery within 30 days of enrollment.
    1. Subject has an active or latent infection which is systemic or at the intended surgery site.
    1. Subject is immuno-compromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders.
    1. Subject is pregnant by a positive pregnancy test or has plans to become pregnant during the study period or is currently breast-feeding.
    1. Subject is unwilling to receive blood products.
    1. Subject has participated in another investigational research study within 30 days of enrollment.
    1. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
158 participants (actual)

Study arms

  • Experimental
    Progel Vascular Sealant

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

    Device: Progel Vascular Sealant

  • Active comparator
    Gelfoam Plus

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

    Device: Gelfoam Plus

Interventions

  • DeviceProgel Vascular Sealant

    Also known as: Progel

  • DeviceGelfoam Plus

    Also known as: Gelfoam

06

What researchers measure

Primary outcomes

  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.

    Time frame: 0 seconds to 600 seconds

Secondary outcomes

  1. Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.

    Time frame: 5 minutes after application

  2. 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

  3. Chest Tube Drainage Volume Following Surgery.

    Time frame: 24 hours post procedure

  4. Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery

    Time frame: 24 hours post procedure

  5. Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.

    Time frame: Intra-procedurally

  6. Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.

    Time frame: 30 days post procedure

  7. Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days

    Time frame: 30 days post procedure

07

Results

Posted Jan 9, 2017

Participant flow

Participant flow — Overall Study
MilestoneProgel Vascular SealantGelfoam Plus
Started10751
Completed10449
Not completed32
Withdrew: Death21
Withdrew: Randomized but not treated11

Outcome measures

PrimaryTime 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
Reported as:
Mean · seconds
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.
secondsProgel Vascular SealantGelfoam 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.124.3 ± 202.09377.8 ± 252.4
Statistical analysis
  • Progel Vascular Sealant vs Gelfoam Plus · Wilcoxon Rank-Sum Test · p = <0.0001
SecondaryProportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.
Time frame:
5 minutes after application
Reported as:
Number · percentage of participants
Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.
percentage of participantsProgel Vascular SealantGelfoam Plus
Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.85.740.0
Statistical analysis
  • Progel Vascular Sealant vs Gelfoam Plus · Regression, Logistic · p = <0.0001 · Odds ratio (or): 9.00 · 95% CI 4.07 to 19.89
SecondaryProportion 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
Reported as:
Number · percentage of participants
Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.
percentage of participantsProgel Vascular SealantGelfoam Plus
Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.59.416.0
Statistical analysis
  • Progel Vascular Sealant vs Gelfoam Plus · Regression, Logistic · p = <0.0001 · Odds ratio (or): 7.69 · 95% CI 3.27 to 18.11
SecondaryChest Tube Drainage Volume Following Surgery.
Time frame:
24 hours post procedure
Reported as:
Mean · mL
Chest Tube Drainage Volume Following Surgery.
mLProgel Vascular SealantGelfoam Plus
Chest Tube Drainage Volume Following Surgery.701.6 ± 499.83589.6 ± 359.41
SecondaryProportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery
Time frame:
24 hours post procedure
Reported as:
Number · participants
Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery
participantsProgel Vascular SealantGelfoam Plus
Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery4619
SecondaryTime Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.
Time frame:
Intra-procedurally
Reported as:
Mean · minutes
Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.
minutesProgel Vascular SealantGelfoam Plus
Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.59.4 ± 30.9658.5 ± 24.74
SecondaryIncidence of Reoperations for Aortic Bleeding Complications Following Treatment.
Time frame:
30 days post procedure
Reported as:
Number · participants
Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.
participantsProgel Vascular SealantGelfoam Plus
Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.01
SecondaryProportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days
Time frame:
30 days post procedure
Reported as:
Number · participants
Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days
participantsProgel Vascular SealantGelfoam Plus
Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days34

Adverse events

Collected over Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Progel Vascular Sealant—51/106 (48.1%)51/106 (48.1%)
Gelfoam Plus—29/50 (58%)29/50 (58%)
Most frequent serious events
Showing 10 of 57
Most frequent serious events
EventProgel Vascular SealantGelfoam Plus
Atrial fibrillationCardiac disorders27/10617/50
Atrial flutterCardiac disorders2/1063/50
PneumothoraxRespiratory, thoracic and mediastinal disorders5/1063/50
AnemiaBlood and lymphatic system disorders5/1061/50
Pleural effusionRespiratory, thoracic and mediastinal disorders5/1061/50
Cardiac arrestCardiac disorders1/1062/50
Ventricular fibrillationCardiac disorders0/1062/50
Cerebrovascular accidentNervous system disorders1/1062/50
ThrombocytopeniaBlood and lymphatic system disorders0/1061/50
Atrioventricular blockCardiac disorders2/1061/50
Most frequent other events
Showing 10 of 26
Most frequent other events
EventProgel Vascular SealantGelfoam Plus
Pleural EffusionRespiratory, thoracic and mediastinal disorders38/10617/50
AtelectasisRespiratory, thoracic and mediastinal disorders36/10615/50
AnemiaBlood and lymphatic system disorders34/10612/50
LeukocytosisBlood and lymphatic system disorders25/10613/50
ThrombocytopeniaBlood and lymphatic system disorders19/1067/50
Oedema PeripheralGeneral disorders18/1064/50
Fluid OverloadMetabolism and nutrition disorders10/1068/50
NauseaGastrointestinal disorders15/1067/50
Atrial FibrillationCardiac disorders13/1067/50
HypotensionVascular disorders13/1064/50

Baseline characteristics

All participants who were randomized and treated

Age, Continuous
Age, Continuous(years)Progel Vascular SealantGelfoam PlusTotal
Mean61.5 ± 14.4262.4 ± 14.3061.8 ± 14.34
Sex: Female, Male
Sex: Female, Male(Participants)Progel Vascular SealantGelfoam PlusTotal
Female321547
Male7435109
Region of Enrollment
Region of Enrollment(participants)Progel Vascular SealantGelfoam PlusTotal
United States10650156
08

Study locations

19 sites
  • Cedars-Sinai
    Los Angeles, California 90048, United States
  • University of Colorado
    Aurora, Colorado 80045, United States
  • University of Florida
    Gainesville, Florida 32610, United States
  • Portneuf Hospital
    Pocatello, Idaho 83201, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Mayo Clinic Hospital
    Rochester, Minnesota 55905, United States
  • Washington University
    St. Louis, Missouri 63110, United States
  • Bryan Heart
    Lincoln, Nebraska 68510, United States
  • Montefiore Medical Center
    Bronx, New York 10467, United States
  • Cornell University
    New York, New York 10021, United States
  • Carolinas Health Care System
    Charlotte, North Carolina 28203, United States
  • Ohio Health Research Institute
    Columbus, Ohio 43214, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Houston Methodist Hospital
    Houston, Texas 77030, United States
  • The Heart Hospital Baylor
    Plano, Texas 75093, United States
  • Intermountain Medical Center
    Murray, Utah 84107, United States
  • University of Virginia Health Sciences Center
    Charlottesville, Virginia 22904, United States
  • Virginia Commonwealth University Medical Center
    Richmond, Virginia 23298, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01959503
Lead sponsor
C. R. Bard
Responsible party
Sponsor
First posted
Oct 10, 2013
Start date
Nov 2013
Primary completion
Dec 2014
Completion
Dec 2014
Results posted
Jan 9, 2017
Last update
Apr 10, 2017

Study contacts

Ali Khoynezhad, MD
principal investigator · Cedars-Sinai Heart Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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