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TRANSFIX Zenith® Transection Clinical Study

NCT01688050 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-11-18

Study results available
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Summary

The TRANSFIX study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® TX2® Low Profile Endovascular Graft for treatment of Blunt Thoracic Aortic Injury.

Conditions

  • Thoracic Aorta
  • Thoracic Injuries
  • Blunt Injuries

Interventions

DEVICE

Zenith® TX2® Low Profile Endovascular Graft

Treatment of Blunt thoracic aortic injuries (BTAIs)

Sponsors & Collaborators

  • Cook Research Incorporated

    lead INDUSTRY

Principal Investigators

  • Benjamin Starnes, MD · University of Washington - Harborview, Division of Vascular Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-23
Primary Completion
2014-06-30
Completion
2019-07-29
FDA Device
Yes

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 NCT01688050 on ClinicalTrials.gov