STARZ-TX2 Clinical Study: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft (STARZ-TX2)

August 15, 2014 updated by: Cook Group Incorporated

Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft

The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA [Thoracic Aortic Aneurysm] Endovascular Graft) is a clinical trial approved by the United States Food and Drug Administration (FDA) to study the safety and effectiveness of the Zenith TX2 TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA Endovascular Graft) is a clinical trial approved by the FDA to study the safety and effectiveness of the Zenith TX2(R) TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers. Instead of making a large incision in the chest, the physician makes a small incision near the groin to insert and guide the graft into place in the aorta, relieving pressure on the aneurysm and helping to reduce the risk of rupture.

The Zenith TX2 TAA Endovascular Graft is a reinforced fabric tube that is sized to the length of the aorta that needs to be covered to seal off the aneurysm / ulcer. The graft is made of a polyester material like that used in open surgical repair. Standard surgical suture is used to sew the graft material to a frame of self-expanding stainless steel stents, which provide support. The materials used in the Zenith TX2 system have a long history of use in medical implants.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y-6J4
        • Peter Lougheed Center
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Vancouver Hospital and Health Science Center
  • Italy
      • Milan, Italy, 20132
        • San Raffaele Hospital
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Banner Desert Medical Center
      • Phoenix, Arizona, United States, 85006
        • Arizona Heart Institute
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • Stanford, California, United States, 94305
        • Stanford University Hospital and Clinics
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Baltimore, Maryland, United States, 21218
        • Union Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • New York, New York, United States, 10016
        • New York University Hospital
      • New York, New York, United States, 10021
        • Lenox Hill Hospital
      • New York, New York, United States, 10021
        • New York Presbyterian - Cornell
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital - Columbia
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • MeritCare
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • Ohio State University
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with aneurysms / ulcers of the descending thoracic aorta
  • Patients who are candidates for either surgery or endovascular repair
  • Patients at least 18 years old

Exclusion Criteria:

  • Age < 18 years
  • Patients with other medical condition (e.g., cancer, congestive heart failure) that may cause non-compliance with the protocol, confound the results, or with limited life expectancy (i.e., less than 2 years)
  • Patients pregnant, breast-feeding, or planning on becoming pregnant within 24 months
  • Patients unwilling or unable to comply with the follow-up schedule
  • Patients unable or who refuse to give informed consent
  • Patients simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Endovascular Repair
Device: Endovascular repair
Endovascular repair.
Other Names:
  • TEVAR
Other: 2
Surgical
Procedure: Surgical
Surgical endovascular repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary hypothesis for effectiveness is that patients treated with the Zenith TX2(R) TAA Endovascular Graft will have equivalent 30-day rupture-free survival compared to the surgical control.
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
A secondary hypothesis is subjects treated with the Zenith TX2(R) TAA Endovascular Graft will have equivalent or fewer complications compared to the surgical control group through 30 days following implant.
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Collaborators

William Cook Europe
MED Institute, Incorporated
William Cook Australia

Investigators

  • Principal Investigator: Jon Matsumura, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 17, 2005

First Submitted That Met QC Criteria

May 17, 2005

First Posted (Estimate)

May 18, 2005

Study Record Updates

Last Update Posted (Estimate)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 15, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-536
  • 37010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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