Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.
Men with TAAA greater than or equal to 6 cm in diameter
Women with TAAA greater than or equal to 5 cm in diameter
Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year
Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or
Rupture, with hypotension (systolic bp < 90).
Pregnancy or breastfeeding.
Unwillingness or inability to comply with the follow up schedule.
Serious systemic or groin infection.
Parallel
Endovascular treatment of Thoracoabdominal Aortic Aneurysm
DeviceA TAAA is an abnormal enlargement (ballooning out) of the main artery (the aorta) and involves all or part of the aorta in your chest as well as all or part of the aorta in the abdomen. It also involves the part of the aorta where the arteries that bring blood to the liver, stomach and intestines and kidneys are attached. This investigational procedure that is being studied uses stent-grafts (cylindrical fabric tubes (grafts), with metal springs (stents) attached). The stent-grafts are placed inside the aneurysmal (weakened) area of the aorta to re-line it. These customized stent-grafts have special branches attached to them or openings (called "fenestrations") that are used to keep blood flowing to the arteries that supply the liver, stomach, intestines and kidneys. The investigational stent graft will be designed and custom-made specifically for your aneurysm.
Endovascular treatment of Aortic Arch Aneurysms
DeviceAn aortic arch aneurysm is an abnormal enlargement (ballooning out) of the main artery (the aorta). The ascending aorta and aortic arch is the first part of the vessel as it exits the heart and makes a turn around the area of the collar bone. This part of the aorta gives branches that supply the head, brain and arms. The arch branch endovascular graft includes the main aortic arch portion and one to three cuffs (side branches) that allow the graft to be located in the aortic arch. The number of cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively.
Technical Success
Successful deployment of the TAAA device or Physician-Specified TAAA Devices, or Aortic Arch device \& bridging covered stents into all targeted mesenteric \& renal, or supra-aortic arteries with stent-graft \& all branches patent by intraop angiography
Procedural Success
Technical success plus freedom from type I or III endoleak, loss of target vessel patency, death, major stroke, paralysis, new onset permanent hemodialysis, major amputation, \& bowel infarction following deployment of the branched stent-graft.
Freedom from aneurysm-related mortality at 1 year
Survival from aneurysm-related death.
Treatment success at 12 months post-procedure
Composite endpoint which includes Technical Success, Procedural Success, and freedom from aneurysm-related mortality
Target artery patency
Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate target artery patency.
Freedom from all-cause mortality
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN \[Urea Nitrogen\], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.
Freedom from reintervention
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN \[Urea Nitrogen\], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation to determine if reintervention with the device is necessary.
Freedom from endoleak
Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.
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Darren Schneider, M.D.
Lead sponsor
University of Pennsylvania
Sponsor institution
