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

Sponsor:	Cook
Collaborators:	William Cook Europe William Cook MED Institute, Incorporated
Information provided by:	Cook
ClinicalTrials.gov Identifier:	NCT00111176

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. The study was closed to enrollment 7/6/2006 and patients are in long-term follow-up.

Condition	Intervention
Thoracic Aortic Aneurysm	Device: Endovascular repair Procedure: Surgical

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm Surgery

U.S. FDA Resources

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
Estimated Study Completion Date:	March 2013
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Endovascular Repair	Device: Endovascular repair Endovascular repair.
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

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

Show 40 Study Locations

Sponsors and Collaborators

Cook

William Cook Europe

William Cook

MED Institute, Incorporated

Investigators

Principal Investigator:

Jon Matsumura, MD

Northwestern University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Cook Incorporated ( April Lavender, Vice President for Regulatory Affairs )
Study ID Numbers:	03-536, 37010
Study First Received:	May 17, 2005
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00111176 History of Changes
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

Additional relevant MeSH terms:

Aortic Diseases
Aortic Aneurysm, Thoracic
Aneurysm

Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm

ClinicalTrials.gov processed this record on November 25, 2009