ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

Last updated: December 20, 2012
Sponsor: Tenaxis Medical, Inc.
Overall Status: Completed

Phase

3

Condition

Claudication

Atherosclerosis

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT00759681
CLN-004
IDE Number - G070211
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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/arterialreconstruction/hemodialysis access/arteriotomy.

  3. The subject has no child bearing potential or has a negative serum or urine pregnancytest 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 isreviewed and approved by the IRB.

Exclusion

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 orseafood products.

  2. The subject has a history of bleeding diathesis or coagulopathy, or will refuse bloodtransfusions.

  3. The subject is currently enrolled in this, or another investigational device or drugtrial (IDE or IND) that has not completed the required follow-up period. Note:Extended follow-up trials for products that were investigational but are currentlycommercially available are not considered investigational trials.

Study Design

Total Participants: 217
Study Start date:
September 01, 2008
Estimated Completion Date:
March 31, 2010

Study 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.

Connect with a study center

  • Greenville Memorial Hospital

    Greenville, South Carolina 29615
    United States

    Site Not Available

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