NCT00759681

ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Tenaxis Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Vascular Disease

Interventions

Type	Name	Description
DEVICE	ArterX Surgical Sealant	Apply at the suture site.
DEVICE	Gelfoam and Thrombin	Apply at the suture site.

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2008-09-25
• Last updated: 2013-01-31
• Results posted: 2013-01-31

Locations

1 site across 1 country: United States