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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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.

Detailed Summary:

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.

Sponsor: Cook

Current Primary Outcome: 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 ]

Original Primary Outcome: 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.

Current Secondary Outcome: 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 ]

Original Secondary Outcome: 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.

Information By: Cook

Dates:
Date Received: May 17, 2005
Date Started: March 2004
Date Completion:
Last Updated: August 15, 2014
Last Verified: August 2014