STARZ-TX2 Clinical Study: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft
STARZ-TX2
Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft
2 other identifiers
interventional
260
3 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2004
Longer than P75 for not_applicable
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 17, 2005
CompletedFirst Posted
Study publicly available on registry
May 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedAugust 18, 2014
August 1, 2014
3.3 years
May 17, 2005
August 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (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
Study Arms (2)
1
OTHEREndovascular Repair
2
OTHERSurgical
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cook Group Incorporatedlead
- William Cook Europecollaborator
- William Cook Australiacollaborator
- MED Institute, Incorporatedcollaborator
Study Sites (41)
Banner Desert Medical Center
Mesa, Arizona, 85202, United States
Arizona Heart Institute
Phoenix, Arizona, 85006, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Stanford University Hospital and Clinics
Stanford, California, 94305, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Florida
Gainesville, Florida, 32610, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
St. Vincent Hospital
Indianapolis, Indiana, 46260, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Albany Medical Center
Albany, New York, 12208, United States
New York University Hospital
New York, New York, 10016, United States
Lenox Hill Hospital
New York, New York, 10021, United States
New York Presbyterian - Cornell
New York, New York, 10021, United States
New York Presbyterian Hospital - Columbia
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeritCare
Fargo, North Dakota, 58122, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Peter Lougheed Center
Calgary, Alberta, T1Y-6J4, Canada
Vancouver Hospital and Health Science Center
Vancouver, British Columbia, V6T 2B5, Canada
San Raffaele Hospital
Milan, 20132, Italy
Related Publications (1)
Matsumura JS, Melissano G, Cambria RP, Dake MD, Mehta S, Svensson LG, Moore RD; Zenith TX2 Clinical Trial Investigators. Five-year results of thoracic endovascular aortic repair with the Zenith TX2. J Vasc Surg. 2014 Jul;60(1):1-10. doi: 10.1016/j.jvs.2014.01.043. Epub 2014 Mar 14.
PMID: 24636714DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Matsumura, MD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2005
First Posted
May 18, 2005
Study Start
March 1, 2004
Primary Completion
July 1, 2007
Study Completion
May 1, 2013
Last Updated
August 18, 2014
Record last verified: 2014-08