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

Sponsor
Cook Group Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00111176
Collaborator
William Cook Europe (Industry), William Cook Australia (Industry), MED Institute, Incorporated (Industry)
260
Enrollment
41
Locations
2
Arms
110
Duration (Months)
6.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Endovascular repair
  • Procedure: Surgical
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
260 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft
Study Start Date :
Mar 1, 2004
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: 1

Endovascular Repair

Device: Endovascular repair
Endovascular repair.
Other Names:
  • TEVAR

    		•
    Other: 2

    Surgical

    Procedure: Surgical
    Surgical endovascular repair

    Outcome Measures

    Primary Outcome Measures

    1. 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. [30 days]

    Secondary Outcome Measures

    1. 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. [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner Desert Medical Center Mesa Arizona United States 85202
    2 Arizona Heart Institute Phoenix Arizona United States 85006
    3 University of California, San Francisco San Francisco California United States 94143
    4 Stanford University Hospital and Clinics Stanford California United States 94305
    5 Swedish Medical Center Englewood Colorado United States 80113
    6 Washington Hospital Center Washington District of Columbia United States 20010
    7 University of Florida Gainesville Florida United States 32610
    8 Mayo Clinic Jacksonville Florida United States 32224
    9 Emory University Atlanta Georgia United States 30322
    10 Northwestern University Chicago Illinois United States 60611
    11 St. Vincent Hospital Indianapolis Indiana United States 46260
    12 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    13 University of Maryland Medical Center Baltimore Maryland United States 21201
    14 Union Memorial Hospital Baltimore Maryland United States 21218
    15 Massachusetts General Hospital Boston Massachusetts United States 02114
    16 University of Michigan Ann Arbor Michigan United States 48109
    17 Barnes-Jewish Hospital St. Louis Missouri United States 63110
    18 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    19 Newark Beth Israel Medical Center Newark New Jersey United States 07112
    20 Albany Medical Center Albany New York United States 12208
    21 New York University Hospital New York New York United States 10016
    22 Lenox Hill Hospital New York New York United States 10021
    23 New York Presbyterian - Cornell New York New York United States 10021
    24 New York Presbyterian Hospital - Columbia New York New York United States 10032
    25 University of Rochester Rochester New York United States 14642
    26 University of North Carolina Chapel Hill North Carolina United States 27599
    27 Duke University Medical Center Durham North Carolina United States 27710
    28 MeritCare Fargo North Dakota United States 58122
    29 Cleveland Clinic Cleveland Ohio United States 44195
    30 Ohio State University Columbus Ohio United States 43210
    31 Riverside Methodist Hospital Columbus Ohio United States 43214
    32 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    33 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    34 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    35 Baylor College of Medicine Houston Texas United States 77030
    36 Memorial Hermann Hospital Houston Texas United States 77030
    37 University of Virginia Charlottesville Virginia United States 22908
    38 Sentara Norfolk General Hospital Norfolk Virginia United States 23507
    39 Peter Lougheed Center Calgary Alberta Canada T1Y-6J4
    40 Vancouver Hospital and Health Science Center Vancouver British Columbia Canada V6T 2B5
    41 San Raffaele Hospital Milan Italy 20132

    Sponsors and Collaborators

    • Cook Group Incorporated
    • William Cook Europe
    • William Cook Australia
    • MED Institute, Incorporated

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cook Group Incorporated
    ClinicalTrials.gov Identifier:
    NCT00111176
    Other Study ID Numbers:
    • 03-536
    • 37010
    First Posted:
    May 18, 2005
    Last Update Posted:
    Aug 18, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by Cook Group Incorporated
    Thoracic Aortic Aneurysm
    Descending
    minimally invasive
    endovascular
    rupture
    back pain
    stent graft
    endovascular aneurysm repair
    aortic aneurysm
    thoracic
    Additional relevant MeSH terms:
    Aneurysm
    Aortic Aneurysm
    Aortic Aneurysm, Thoracic

    Study Results

    No Results Posted as of Aug 18, 2014