Vascular DiseasePhase 3StEPSNCT00759681
ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial
A Phase 3 study testing ArterX Surgical Sealant and Gelfoam and Thrombin in people with Vascular Disease, run by Tenaxis Medical, Inc. at 1 site in United States.
Trial summary
This is a prospective, multi-center randomized, controlled study. The study is designed to assess the safety effectiveness of the ArterX Vascular Sealant compared to the control group in the open surgical repair of large vessels using synthetic vascular grafts or patches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Disease
- What is being tested?
- ArterX Surgical Sealant and Gelfoam and Thrombin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Mar 2010
- Phase
- Phase 3
- 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
- Subject must meet all of the following criteria to be eligible for treatment in the Study:
- The subject must be equal or greater than 18 years old.
- The subject must be scheduled for the surgical placement of a synthetic (i.e., PTFE/Dacron) vascular graft or patch for large vessel repair/arterial reconstruction/hemodialysis access/arteriotomy.
- The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure.
- The subject is willing and able to be contacted for the follow up visits at 6 weeks (± 7 days) and 3 months (± 7 days).
- The subject or guardian must provide written informed consent using a form that is reviewed and approved by the IRB.
Who cannot join
- Subjects will be excluded from the Study if any of the following criteria are met:
- The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products.
- The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusions.
- The subject is currently enrolled in this, or another investigational device or drug trial (IDE or IND) that has not completed the required follow-up period. Note: Extended follow-up trials for products that were investigational but are currently commercially available are not considered investigational trials.
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Memorial Hospital
Greenville, South Carolina, 29615
About this study
Official title: A Prospective, Multi-center, Randomized Study to Evaluate the Safety and Efficacy of ArterX Vascular Sealant.
This is a prospective, multi-center randomized, controlled study. The study is designed to assess the safety effectiveness of the ArterX Vascular Sealant compared to the control group in the open surgical repair of large vessels using synthetic vascular grafts or patches.
Read the detailed description
To evaluate, during open vascular surgery, the safety and effectiveness of the ArterX™ Vascular Sealant when applied prophylactically. Application will be at synthetic vascular graft or patch to native vessel anastomosis prior to the restoration of full systemic circulation to achieve suture line sealing.
- Conditions
- Vascular Disease
- Being tested
- ArterX Surgical Sealant, Gelfoam and Thrombin
- Keywords
- Arterial Surgery, Open vascular Surgery, Sealant
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArterX Surgical SealantDevice
Also called ArterX Vascular Sealant
Apply at the suture site.
Gelfoam and ThrombinDevice
Also called Gelfoam Plus
Apply at the suture site.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Gelfoam and Thrombin Receives: Device: Gelfoam and Thrombin |
| Investigational Device | Experimental | ArterX Surgical Sealant Receives: Device: ArterX Surgical Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Sealing Evidenced by no Bleeding on Clamp Release.
The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery
Measured: Immediate at time of surgery
Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response
The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.
Measured: Treatment through 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2009
- Study completionMar 2010
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 Vascular DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tenaxis Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Cull, MD, Principal investigator, Greenville Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759681
- Sponsor's protocol ID
- CLN-004
- Other IDs
- IDE Number - G070211
- Acronym
- StEPS
- Status last verified
- Dec 2012
- First submitted
- 23 Sep 2008
- Last updated
- 31 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Stone WM, Cull DL, Money SR. A randomized prospective multicenter trial of a novel vascular sealant. Ann Vasc Surg. 2012 Nov;26(8):1077-84. doi: 10.1016/j.avsg.2012.02.013. Epub 2012 Aug 29.
PubMed 22939276
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Study to Evaluate the Safety and Efficacy of ArterX Vascular Sealant.
- ClinicalTrials.gov ID
- NCT00759681
- Acronym / sponsor ID
- StEPS / CLN-004
- Conditions
- Vascular Disease
- Keywords
- Arterial Surgery, Open vascular Surgery, Sealant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Tenaxis Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 31 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center randomized, controlled study. The study is designed to assess the safety effectiveness of the ArterX Vascular Sealant compared to the control group in the open surgical repair of large vessels using synthetic vascular grafts or patches.
Detailed description
To evaluate, during open vascular surgery, the safety and effectiveness of the ArterX™ Vascular Sealant when applied prophylactically. Application will be at synthetic vascular graft or patch to native vessel anastomosis prior to the restoration of full systemic circulation to achieve suture line sealing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Gelfoam and ThrombinGelfoam and Thrombin |
| Investigational Device | Experimental | Device: ArterX Surgical SealantArterX Surgical Sealant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must meet all of the following criteria to be eligible for treatment in the Study:
- The subject must be equal or greater than 18 years old.
- The subject must be scheduled for the surgical placement of a synthetic (i.e., PTFE/Dacron) vascular graft or patch for large vessel repair/arterial reconstruction/hemodialysis access/arteriotomy.
- The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure.
- The subject is willing and able to be contacted for the follow up visits at 6 weeks (± 7 days) and 3 months (± 7 days).
Key exclusion criteria (4 listed)
- The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products.
- The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusions.
- The subject is currently enrolled in this, or another investigational device or drug trial (IDE or IND) that has not completed the required follow-up period. Note: Extended follow-up trials for products that were investigational but are currently commercially available are not considered investigational trials.
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 |
|---|---|---|
| ArterX Surgical SealantAlso: ArterX Vascular SealantApply at the suture site. | Device | Investigational Device |
| Gelfoam and ThrombinAlso: Gelfoam PlusApply at the suture site. | Device | Control |
Primary outcome
Immediate Sealing Evidenced by no Bleeding on Clamp Release.
Time frame: Immediate at time of surgery
The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery
Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response
Time frame: Treatment through 6 weeks
The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22939276Stone WM, Cull DL, Money SR. A randomized prospective multicenter trial of a novel vascular sealant. Ann Vasc Surg. 2012 Nov;26(8):1077-84. doi: 10.1016/j.avsg.2012.02.013. Epub 2012 Aug 29.
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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.
David Cull, MD principal investigator
Greenville Hospital System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ArterX Surgical Sealant and Gelfoam and Thrombin in people with Vascular Disease, run by Tenaxis Medical, Inc. at 1 site 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 6 inclusion and 4 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 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2013). 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?
Immediate Sealing Evidenced by no Bleeding on Clamp Release. (time frame: Immediate at time of surgery). The study lists 2 primary outcomes in all. 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 NCT00759681, 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 31 Jan 2013.