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

Tracking Information

First Received Date ^ICMJE

May 17, 2005

Last Updated Date

July 13, 2009

Start Date ^ICMJE

March 2004

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00111176 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Thoracic Aortic Aneurysm

Intervention ^ICMJE

Device: Endovascular repair
Procedure: Surgical

Study Arms / Comparison Groups

Other: Endovascular Repair
Other: Surgical

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

205

Estimated Completion Date

March 2013

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00111176

Responsible Party

April Lavender, Vice President for Regulatory Affairs, Cook Incorporated

Study ID Numbers ^ICMJE

03-536, 37010

Study Sponsor ^ICMJE

Cook

Collaborators ^ICMJE

William Cook Europe
William Cook
MED Institute, Incorporated

Investigators ^ICMJE

Principal Investigator:

Jon Matsumura, MD

Northwestern University

Information Provided By

Cook

Verification Date

July 2009

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