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

This study has been completed.
Sponsor:
Collaborators:
William Cook Europe
William Cook Australia
MED Institute, Incorporated
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00111176
First received: May 17, 2005
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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 Intervention
Thoracic Aortic Aneurysm
Device: Endovascular repair
Procedure: Surgical

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 205
Study Start Date: March 2004
Study Completion Date: February 2014
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Endovascular Repair
Device: Endovascular repair
Endovascular repair.
Other Name: TEVAR
2
Surgical
Procedure: Surgical
Surgical endovascular repair

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111176

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

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00111176     History of Changes
Other Study ID Numbers: 03-536, 37010
Study First Received: May 17, 2005
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Cook:
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
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 23, 2014