Aortic Valve StenosisNCT01959503
Progel Vascular Sealant
A study testing Progel Vascular Sealant and Gelfoam Plus in people with Aortic Valve Stenosis and Aneurysm of Ascending Aorta, run by C. R. Bard at 19 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder
- What is being tested?
- Progel Vascular Sealant and Gelfoam Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 19 sitesUnited States
- Study dates
- Nov 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
Carolinas Health Care System
Charlotte, North Carolina, 28203
University of Virginia Health Sciences Center
Charlottesville, Virginia, 22904
Northwestern University
Chicago, Illinois, 60611
Ohio Health Research Institute
Columbus, Ohio, 43214
University of Florida
Gainesville, Florida, 32610
Houston Methodist Hospital
Houston, Texas, 77030
Bryan Heart
Lincoln, Nebraska, 68510
Cedars-Sinai
Los Angeles, California, 90048
Intermountain Medical Center
Murray, Utah, 84107
Cornell University
New York, New York, 10021
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Heart Hospital Baylor
Plano, Texas, 75093
Portneuf Hospital
Pocatello, Idaho, 83201
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
Mayo Clinic Hospital
Rochester, Minnesota, 55905
Washington University
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
About this study
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
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).
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Being tested
- Progel Vascular Sealant, Gelfoam Plus
- Keywords
- Aorta, Aortic, Reconstruction, CABG, Bypass
- Medical subject headings
- Aortic Valve Stenosis, Aneurysm, Ascending Aorta, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progel Vascular SealantDevice
Also called Progel
Gelfoam PlusDevice
Also called Gelfoam
| Study group | Role | What they receive |
|---|---|---|
| Progel Vascular Sealant | Experimental | Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Receives: Device: Progel Vascular Sealant |
| Gelfoam Plus | Active comparator | Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Receives: Device: Gelfoam Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 seconds to 600 seconds
Secondary outcomes (7)
Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.
Measured: 5 minutes after application
Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.
Measured: 0 seconds to 10 minutes
Chest Tube Drainage Volume Following Surgery.
Measured: 24 hours post procedure
Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery
Measured: 24 hours post procedure
Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.
Measured: Intra-procedurally
Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.
Measured: 30 days post procedure
Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ali Khoynezhad, MD, Principal investigator, Cedars-Sinai Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959503
- Sponsor's protocol ID
- NEO13-100
- Status last verified
- Apr 2017
- First submitted
- 8 Oct 2013
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 38695613
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01959503
- Acronym / sponsor ID
- NEO13-100
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Keywords
- Aorta, Aortic, Reconstruction, CABG, Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Posted 9 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progel Vascular Sealant | Experimental | Device: Progel Vascular SealantProgel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. |
| Gelfoam Plus | Active comparator | Device: Gelfoam PlusGelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progel Vascular SealantAlso: Progel | Device | Progel Vascular Sealant |
| Gelfoam PlusAlso: Gelfoam | Device | Gelfoam Plus |
Primary outcome
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
7 secondary outcomes
Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.
Time frame: 5 minutes after application
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
Chest Tube Drainage Volume Following Surgery.
Time frame: 24 hours post procedure
Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery
Time frame: 24 hours post procedure
Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.
Time frame: Intra-procedurally
Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.
Time frame: 30 days post procedure
Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days
Time frame: 30 days post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38695613Ma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Khoynezhad, MD principal investigator
Cedars-Sinai Heart Institute
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progel Vascular Sealant and Gelfoam Plus in people with Aortic Valve Stenosis and Aneurysm of Ascending Aorta, run by C. R. Bard at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01959503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.