ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial (StEPS)
December 20, 2012 updated by: Tenaxis Medical, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
217
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Greenville, South Carolina, United States, 29615
- Greenville Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
Gelfoam and Thrombin
|
Apply at the suture site.
Other Names:
|
|
Experimental: Investigational Device
ArterX Surgical Sealant
|
Apply at the suture site.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Immediate 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.
|
Treatment through 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Cull, MD, Greenville Hospital System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
September 23, 2008
First Submitted That Met QC Criteria
September 23, 2008
First Posted (Estimate)
September 25, 2008
Study Record Updates
Last Update Posted (Estimate)
January 31, 2013
Last Update Submitted That Met QC Criteria
December 20, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLN-004
- IDE Number - G070211
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.