Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

Ki vehet részt

• Aortic aneurysm involving the visceral vessels requiring treatment defined as at least one of the following:; Fusiform aneurysm diameter ≥ 5 cm; Saccular aneurysm (no diameter requirement); Rapid aneurysm growth (≥ 5 mm in one year)
• Aortic aneurysm that involves the abdominal aorta, with:; Involvement of at least one visceral vessel and aneurysmal extension as far as 65 mm proximal to the celiac artery, and/or; No normal aorta between the upper extent of aneurysm and renal artery(s)
• Adequate access for TAMBE Device components (femoral, axillary, and / or brachial arteries as required)
• Age ≥ 19 years at the time of informed consent signature
• Male or infertile female
• Patient assessment favors an endovascular approach when compared to open surgical repair, as deemed by the treating physician
• Capable of complying with protocol requirements, including follow-up
• An Informed Consent Form signed by Subject or legal representative
• Sufficient distal landing zones in both iliac arteries, with at least one patent internal iliac artery and without planned placement of a branched iliac device, or planned coverage/occlusion/embolization of any patent internal iliac artery
• Appropriate aortic anatomy to receive the TAMBE Device defined as all of the following:; For the TAMBE aortic component, proximal aortic landing zone diameters between 22-34 mm; Proximal seal zone ≥ 20 mm in length; Aortic neck angle ≤ 60°; Distal landing zone (iliac arteries) 8-25 mm; Distal seal zone in iliac arteries of at least 10 mm in length; Renal artery landing zone diameters between 4-10 mm; Celiac and superior mesenteric artery landing zone diameters between 5-12 mm; ≥ 15 mm landing zone in each branch vessel; Landing zones in the proximal and distal aorta and all branch vessels cannot be aneurysmal, heavily calcified, or heavily thrombosed; Patent left subclavian artery; Secondary Study Arm Only:
• If aneurysm extends greater than 65 mm above celiac artery, proximal extension with a CTAG Device is required. The aortic landing zone diameter treatment range with the CTAG Device is 19.5-32 mm
• The most proximal aspect of the aneurysm is at least 2.0 cm distal to the left subclavian artery
• The most proximal aortic device seal zone will be within native aorta or a previously-deployed TAG or CTAG Device • Placement inside a Dacron graft or another device manufacturer's stent graft will not be supported

Ki nem vehet részt

• Prior open, aortic surgery of the ascending aorta or aortic arch
• Participation in an investigational drug study (within 30 days of last administration) or investigational medical device study (within 1 year of implant) from the time of study screening
• Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
• Known concomitant aneurysm of the ascending aorta or aortic arch anticipated to require surgical intervention within one year of study treatment
• Infected aorta
• Myocardial infarction or stroke within 1 year of treatment (staged or index procedure)
• Systemic infection which may increase risk of endovascular graft infection
• Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
• History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment
• Known sensitivities or allergies to the device materials
• Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
• Renal Insufficiency (creatinine value > 1.8 mg/dL, GFR < 30, or patient undergoing dialysis)
• Life expectancy <2 years
• The patient is / has:
• Ruptured or leaking aortic aneurysm
• Aneurysmal dilatation due to chronic aortic dissection
• Mycotic aneurysm
• Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access
• A branch vessel(s) that is dissected or has significant calcification, tortuosity, thrombus formation that would interfere with device delivery or ability to exclude from blood flow