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

ID#: NCT03728985

Age: 19 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: June 17, 2019

End Date: September 01, 2026

Contact Information:
Jennie Wurgler
Jill Ellis-Herr

Prospective, non-randomized, , multicenter study with two independent arms: - Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. - Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis.


Inclusion Criteria:

1. 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)

2. 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)

3. Adequate access for TAMBE Device components (femoral, axillary, and / or brachial arteries as required)

4. Age ≥ 19 years at the time of informed consent signature

5. Male or infertile female

6. Patient assessment favors an endovascular approach when compared to open surgical repair, as deemed by the treating physician

7. Capable of complying with protocol requirements, including follow-up

8. An Informed Consent Form signed by Subject or legal representative

9. 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.

10. 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:

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