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

This study has been completed.
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: February 7, 2014
Last verified: February 2014

May 17, 2005
February 7, 2014
March 2004
July 2007   (final data collection date for primary outcome measure)
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 ]
The primary hypothesis for effectiveness is that patients treated with the Zenith TX2™ THORACIC TAA Endovascular Graft will have equivalent 30-day rupture-free survival compared to the surgical control.
Complete list of historical versions of study NCT00111176 on ClinicalTrials.gov Archive Site
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 ]
A secondary hypothesis is subjects treated with the Zenith TX2™ THORACIC TAA Endovascular Graft will have equivalent or fewer complications compared to the surgical control group through 30 days following implant.
Not Provided
Not Provided
 
STARZ-TX2 Clinical Study: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft
Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft

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 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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Thoracic Aortic Aneurysm
  • Device: Endovascular repair
    Endovascular repair.
    Other Name: TEVAR
  • Procedure: Surgical
    Surgical endovascular repair
  • 1
    Endovascular Repair
    Intervention: Device: Endovascular repair
  • 2
    Surgical
    Intervention: Procedure: Surgical
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
February 2014
July 2007   (final data collection date for primary outcome measure)

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.)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Italy
 
NCT00111176
03-536, 37010
Yes
Cook
Cook
  • William Cook Europe
  • William Cook Australia
  • MED Institute, Incorporated
Principal Investigator: Jon Matsumura, MD University of Wisconsin, Madison
Cook
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP