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

Thoracic Aortic Aneurysm Clinical Trial

— STARZ-TX2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111176
• Other study ID #: 03-536
• Secondary ID: 37010
• Status: Completed
• Phase: N/A
• First received: May 17, 2005
• Last updated: August 15, 2014
• Start date: March 2004
• Est. completion date: May 2013

Study information

• Verified date: August 2014
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: May 2013
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Thoracic Aortic Aneurysm

Intervention

Device:
• Endovascular repair
Endovascular repair.

Procedure:
• Surgical
Surgical endovascular repair

Locations

Country	Name	City	State
Canada	Peter Lougheed Center	Calgary	Alberta
Canada	Vancouver Hospital and Health Science Center	Vancouver	British Columbia
Italy	San Raffaele Hospital	Milan
United States	Albany Medical Center	Albany	New York
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Union Memorial Hospital	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Swedish Medical Center	Englewood	Colorado
United States	MeritCare	Fargo	North Dakota
United States	University of Florida	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Memorial Hermann Hospital	Houston	Texas
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	Mayo Clinic	Jacksonville	Florida
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Banner Desert Medical Center	Mesa	Arizona
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Lenox Hill Hospital	New York	New York
United States	New York Presbyterian - Cornell	New York	New York
United States	New York Presbyterian Hospital - Columbia	New York	New York
United States	New York University Hospital	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Arizona Heart Institute	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	University of California, San Francisco	San Francisco	California
United States	Barnes-Jewish Hospital	St. Louis	Missouri
United States	Stanford University Hospital and Clinics	Stanford	California
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Cook	MED Institute, Incorporated, William Cook Australia, William Cook Europe

Countries where clinical trial is conducted

United States,  Canada,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes