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PRO-A Thoracic Stent-Graft Sytem
||A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO
Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating
Aortic Aneurysm, Atherosclerotic Ulcers, Stent-Grafts
||Payem Salehi, MD
The purpose of this study is to investigate the safety and effectiveness of the Relay PRO Thoracic Stent-Grafts in subjects with aneurysms and Penetrating Atherosclerotic Ulcers (PAUs) within the descending thoracic area.
- Subject has any of the following conditions in his/her descending thoracic aorta
- Aneurysm >= 5.0 cm in diameter
- Aneurysm >= 4.0 cm in diameter with an increase of >= 0.5 cm within the last 6 months or >=1.0 cm over the last 12 months
- Aneurysm with maximum diameter exceeding two times the diameter of the non-aneurysmal, adjacent aorta
- Saccular aneurysm
- PAU within the DTA with a depth of 10 mm or more
- Proximal and distal aortic neck with diameter between 18 mm and 42 mm
- Subject must have a proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery. The length of the attachment zones will depend on the intended stent graft diameter and type of graft selected.
- Acute or chronic aortic dissection within the ascending aorta, arch or descending thoracic
- Intramural hematoma (current or previous)
- Traumatic aortic injury or transection
Subjects will be followed for one year. A CT scan with contrast is required at the screening, 1 month, 6 month, and 12 month appointments (if unable to do a CT with contrast, MRI or ultrasound combined with unenhanced CT may be performed). CT without contrast will be performed at 1 month, 6 month, and 12 month appointments. Chest X-Ray will be performed at 1 month, 6 month, and 12 month appointments. Angiogram will be performed on treatment day. Treatment may be endoscopic or open procedure. There are 5 total visits (screening, treatment, 1 month, 6 month, 12 month) but there could be unscheduled/unplanned appointments per physicians discretion.