Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection

Evaluation of the Safety and Effectiveness Performance of the Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissection Involving the Descending Thoracic Aorta

The purpose of this study is to evaluate the safety and effectiveness performance of the Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the descending thoracic aorta.

The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.

Inclusion Criteria:

• Branch vessel obstruction/compromise
• Peri-aortic effusion/hematoma
• Resistant hypertension
• Persistent pain/symptoms
• Transaortic growth greater than or equal to 5 mm within 3 months (or transaortic diameter greater than or equal to 40 mm)

Exclusion Criteria:

• Age less than 18 years
• Frank rupture
• Diagnosed or suspected congenital degenerative connective tissue disease
• Systemic infection
• Untreatable reaction to contrast
• Surgical/endovascular AAA repair within 30 days
• Previous placement of thoracic endovascular graft
• Prior repair of descending thoracic aorta
• Interventional/open procedures within 30 days
• Onset of symptoms > 3 months