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

  • STATUS
    Recruiting
  • End date
    Sep 25, 2026
  • participants needed
    122
  • sponsor
    W.L.Gore & Associates
Updated on 25 March 2022

Summary

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 additional subjects implanted in Continued Access (Primary Study arm)

Details
Condition Thoracoabdominal Aortic Aneurysm
Treatment GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Clinical Study IdentifierNCT03728985
SponsorW.L.Gore & Associates
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
Distal landing zone (iliac arteries) 8-25 mm
Aortic neck angle ≤ 60°
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

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)
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
Known sensitivities or allergies to the device materials
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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note