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ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial — StEPS  

Vascular Disease Clinical Trial

Official title:
A Prospective, Multi-center, Randomized Study to Evaluate the Safety and Efficacy of ArterX Vascular Sealant.

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00759681
Study type Interventional
Source Tenaxis Medical, Inc.
Contact
Status Completed
Phase Phase 3
Start date September 2008
Completion date March 2010
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