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ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

NCT00759681 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2013-01-31

Study results available
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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.

Conditions

  • Vascular Disease

Interventions

DEVICE

ArterX Surgical Sealant

Apply at the suture site.

DEVICE

Gelfoam and Thrombin

Apply at the suture site.

Sponsors & Collaborators

  • Tenaxis Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • David Cull, MD · Greenville Hospital System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-12-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00759681 on ClinicalTrials.gov