Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)
Raghu Motaganahalli, MD
Primary Investigator
Brief description of study
Prospective, non-randomized, , multicenter study with two independent arms:
- Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis.
- Up to 40 additional subjects may be implanted in Continued Access Phase under t the Primary Study Arm only
- Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis.
Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 40 additionalubjects implanted in Continued Access (Primary Study arm)
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Thoracoabdominal Aortic Aneurysm
-
Age: 19 years or above
-
Gender: All
Inclusion Criteria:
- Aortic aneurysm involving the visceral vessels requiring treatment defined as at leasthe 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 65he 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 surgicaldeemed 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 patenty and without planned placement of a branched iliac device, ord coverage/occlusion/embolization of any patent internal iliac artery.
- Appropriate aortic anatomy to receive the TAMBE Device defined as all of thewing
- For the TAMBE aortic component, proximal aortic landing zone diameters between22-34 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 beurysmal, heavily calcified, or heavily thrombosed
- Patent left subclavian artery
Secondary Study Arm Only:
11. 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
12. The most proximal aspect of the aneurysm is at least 2.0 cm distal to the left
subclavian artery.
13. 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:
1. Prior open, aortic surgery of the ascending aorta or aortic arch
2. Ruptured or leaking aortic aneurysm
3. Aneurysmal dilatation due to chronic aortic dissection
4. Infected aorta
5. Mycotic aneurysm
6. Life expectancy <2 years
7. Myocardial infarction or stroke within 1 year of treatment (staged or index procedure)
8. Systemic infection which may increase risk of endovascular graft infection
9. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
10. 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
11. History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of
treatment
12. Tortuous or stenotic iliac and / or femoral arteries and the inability to use a
conduit for vascular access
13. 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
14. Known sensitivities or allergies to the device materials
15. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known
hypersensitivity to heparin
16. Patient has body habitus or other medical condition which prevents adequate
fluoroscopic and CT visualization of the aorta
17. Renal Insufficiency (creatinine value > 1.8 mg/dL, GFR < 30, or patient undergoing
dialysis)
18. Known concomitant aneurysm of the ascending aorta or aortic arch anticipated to
require surgical intervention within one year of study treatment
