Thoracic Aortic Aneurysm Clinical Trial
Official title:
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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