Ensayos clínicos

Inclusion Criteria:

• 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;
  • Visceral segment of aorta must be ≥ 20 mm in diameter;
  • 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.

Exclusion Criteria:

The patient is / has:

• Prior open, aortic surgery of the ascending aorta or aortic arch.
• Ruptured or leaking aortic aneurysm.
• Aneurysmal dilatation due to chronic aortic dissection.
• Infected aorta.
• Mycotic aneurysm.
• Life expectancy < 2 years.
• Myocardial infarction or stroke within 1 year of treatment (staged or index procedure).
• Life expectancy < 2 years.
• 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.
• 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.
• History of drug abuse; e.g., cocaine or amphetamine or alcohol, within 1 year of treatment.
• 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.
• Known sensitivities or allergies to the device materials.
• Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin.
• 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).
• Known concomitant aneurysm of the ascending aorta or aortic arch anticipated to require surgical intervention within one year of study treatment.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/17/24. Questions regarding updates should be directed to the study team contact.