STARZ-TX2 Clinical Study: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft
- Conditions
- Thoracic Aortic Aneurysm
- Interventions
- Procedure: SurgicalDevice: Endovascular repair
- Registration Number
- NCT00111176
- Lead Sponsor
- Cook Group Incorporated
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Surgical Surgical 1 Endovascular repair Endovascular Repair
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (41)
San Raffaele Hospital
🇮🇹Milan, Italy
Barnes-Jewish Hospital
🇺🇸St. Louis, Missouri, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Stanford University Hospital and Clinics
🇺🇸Stanford, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
New York Presbyterian - Cornell
🇺🇸New York, New York, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Albany Medical Center
🇺🇸Albany, New York, United States
New York University Hospital
🇺🇸New York, New York, United States
New York Presbyterian Hospital - Columbia
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Vancouver Hospital and Health Science Center
🇨🇦Vancouver, British Columbia, Canada
St. Vincent Hospital
🇺🇸Indianapolis, Indiana, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
MeritCare
🇺🇸Fargo, North Dakota, United States
University of Rochester
🇺🇸Rochester, New York, United States
Peter Lougheed Center
🇨🇦Calgary, Alberta, Canada
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Banner Desert Medical Center
🇺🇸Mesa, Arizona, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Arizona Heart Institute
🇺🇸Phoenix, Arizona, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States