ArterX Vascular Sealant - Full Text View

Sponsored by:	Tenaxis Medical, Inc.
Information provided by:	Tenaxis Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00759681

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 Vascular Sealant Device: Gelfoam and Thrombin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Multi-Center, Randomized Study to Evaluate the Safety and Efficacy of ArterX Vascular Sealant.

Resource links provided by NLM:

MedlinePlus related topics: Surgery Vascular Diseases

U.S. FDA Resources

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

Primary Outcome Measures:

Immediate sealing evidenced by no bleeding on clamp release. The primary Safety endpoint will be the cumulative incidence of significant bleeding, infection, neurological deficit or inflammatory/immune allergic response through 6 weeks. [ Time Frame: Duration of the study. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	220
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator Gelfoam and Thrombin	Device: Gelfoam and Thrombin Apply at the suture site.
1: Experimental ArterX Vascular Sealant	Device: ArterX Vascular Sealant Apply at the suture site.

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:

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.

Contacts and Locations

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

Contacts

Contact: Tonya Brantley	650 691 9016 ext 220	tbrantley@tenaxismedical.com
Contact: Roxanne Dubois	650-691-9016 ext 115	rdubois@tenaxismedical.com

Locations

United States, South Carolina
Greenville Memorial Hospital	Recruiting
Greenville, South Carolina, United States, 29615
Contact: David Cull, MD 864-455-9825
Principal Investigator: David Cull, MD

Sponsors and Collaborators

Tenaxis Medical, Inc.

Investigators

Principal Investigator:

David Cull, MD

Greenville Hospital System

More Information

No publications provided

Responsible Party:	Tenaxis Medical, Inc. ( Tonya Brantley )
Study ID Numbers:	CLN-004, IDE Number - G070211
Study First Received:	September 23, 2008
Last Updated:	June 3, 2009
ClinicalTrials.gov Identifier:	NCT00759681 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tenaxis Medical, Inc.:

Open vascular Surgery.

Study placed in the following topic categories:

Thrombin
Vascular Diseases
Gelatin Sponge, Absorbable
Hemostatics

Additional relevant MeSH terms:

Coagulants
Therapeutic Uses
Hematologic Agents
Vascular Diseases

Cardiovascular Diseases
Gelatin Sponge, Absorbable
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on September 11, 2009