NCT00111176

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Cook Group Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Thoracic Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Endovascular repair	Endovascular repair.
PROCEDURE	Surgical	Surgical endovascular repair

Timeline

• Start date: 2004-03-01
• Primary completion: 2007-07-01
• Completion: 2013-05-01
• First posted: 2005-05-18
• Last updated: 2014-08-18

Locations

41 sites across 3 countries: United States, Canada, Italy