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

W.L. Gore & Associates

Status: Active, not recruiting

Conditions: Thoracoabdominal Aortic Aneurysm

Treatments: Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT03728985

AAA 17-01

Details and patient eligibility

About

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 65 additional subjects may be implanted in Continued Access Phase under 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 65 additional subjects implanted in Continued Access (Primary Study arm)

Enrollment: 102 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Primary Study Arm

Active Comparator group

Description:

TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)

Treatment:

Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis

Secondary Study Arm

Experimental group

Description:

TAAA requiring TAMBE System and CTAG Device(s). Crawford Type I-III (n= 20 - 100)

Treatment:

Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis