Gore TAMBE
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StatusAccepting Candidates
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Age19 Years - N/A
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SexesAll
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Healthy VolunteersNo
Objective
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)
Details
Full study title | Evaluation of the GORE? EXCLUDER? Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms |
Protocol number | OCR29362 |
ClinicalTrials.gov ID | NCT03728985 |
Phase | N/A |
Eligibility
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
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
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
Lead researcher
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Martin R Back, MD, FACS, RPVIVascular Surgeon
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
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Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.