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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tenaxis Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00759681
First received: September 23, 2008
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Vascular Disease
Device: ArterX Surgical Sealant
Device: Gelfoam and Thrombin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized Study to Evaluate the Safety and Efficacy of ArterX Vascular Sealant.

Resource links provided by NLM:


Further study details as provided by Tenaxis Medical, Inc.:

Primary Outcome Measures:
  • Immediate Sealing Evidenced by no Bleeding on Clamp Release. [ Time Frame: Immediate at time of surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.


Enrollment: 217
Study Start Date: September 2008
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759681

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

Publications:
Responsible Party: Tenaxis Medical, Inc.
ClinicalTrials.gov Identifier: NCT00759681     History of Changes
Other Study ID Numbers: CLN-004, IDE Number - G070211
Study First Received: September 23, 2008
Results First Received: October 31, 2012
Last Updated: December 20, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Gelatin Sponge, Absorbable
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014