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

Cook Group

Status

Completed

Conditions

Thoracic Aortic Aneurysm

Treatments

Procedure: Surgical

Device: Endovascular repair

Study type

Interventional

Funder types

Industry

Identifiers

NCT00111176

37010

03-536

Details and patient eligibility

About

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.

Full 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.

Enrollment

260 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)