ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial (StEPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00759681
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : January 31, 2013
Last Update Posted : January 31, 2013
Information provided by (Responsible Party):
Tenaxis Medical, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Vascular Disease Device: ArterX Surgical Sealant Device: Gelfoam and Thrombin Phase 3

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  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized Study to Evaluate the Safety and Efficacy of ArterX Vascular Sealant.
Study Start Date : September 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Control
Gelfoam and Thrombin
Device: Gelfoam and Thrombin
Apply at the suture site.
Other Name: Gelfoam Plus
Experimental: Investigational Device
ArterX Surgical Sealant
Device: ArterX Surgical Sealant
Apply at the suture site.
Other Name: ArterX Vascular Sealant

Primary Outcome Measures :
  1. 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

  2. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Subject must meet all of the following criteria to be eligible for treatment in the Study:

  1. The subject must be equal or greater than 18 years old.
  2. 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.
  3. The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure.
  4. The subject is willing and able to be contacted for the follow up visits at 6 weeks (± 7 days) and 3 months (± 7 days).
  5. 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:

  1. The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products.
  2. The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusions.
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00759681

United States, South Carolina
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Tenaxis Medical, Inc.
Principal Investigator: David Cull, MD Greenville Hospital System

Publications of Results:
Responsible Party: Tenaxis Medical, Inc. Identifier: NCT00759681     History of Changes
Other Study ID Numbers: CLN-004
IDE Number - G070211
First Posted: September 25, 2008    Key Record Dates
Results First Posted: January 31, 2013
Last Update Posted: January 31, 2013
Last Verified: December 2012

Keywords provided by Tenaxis Medical, Inc.:
Arterial Surgery
Open vascular Surgery

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Gelatin Sponge, Absorbable