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

This study is ongoing, but not recruiting participants.
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: January 4, 2013
Last verified: January 2013
History of Changes
  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:

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

  Show 41 Study Locations
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

Additional Information:
This site provides information about thoracic aortic aneurysms (TAA) and the STARZ-TX2 study, a landmark clinical study of an endovascular medical device for the treatment of this life-threatening medical condition.  This link exits the ClinicalTrials.gov site

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: January 4, 2013
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 May 22, 2013