Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:
Prospective, non-randomized, multicenter study with two independent arms: 1) Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. 2) Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis.
- 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.