Abdominal Aortic AneurysmNCT06578741
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
A study testing GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in people with Abdominal Aortic Aneurysm and Pararenal Aortic Aneurysm, run by W.L.Gore & Associates at 1 site in United States.
Trial summary
This study aims to confirm that the benefit-risk assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy of the TAMBE Device training program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
- What is being tested?
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2024to 1 Jun 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is / has:
- Treated with the aortic component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Aortic Component) to allow endovascular repair of an aortic disease involving the visceral vessels.
- Age ≥18 years at the time of informed consent signature.
- An Informed Consent Form signed by subject or legal representative.
Who cannot join
- The subject is / has:
- Any contraindications for the TAMBE Device according to the IFU.
- Planned parallel grafting with the TAMBE Aortic Component.
- Intent to modify TAMBE Aortic Component (e.g., in situ fenestration).
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to confirm that the benefit-risk assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy of the TAMBE Device training program.
Read the detailed description
A maximum of 300 adult subjects will be enrolled at up to 60 U.S. centers, with a minimum of 70 subjects enrolled at study centers with no prior experience using the TAMBE Device. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 10 years post implant.
- Being tested
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)Device
Treatment with the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in patients with Pararenal Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Treatment with GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) Receives: Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-Primary Endpoint #1: Technical Success
All of the qualifying criteria are met (in the absence of surgical conversion or mortality, type I or type III endoleak, branch occlusion, or graft limb obstruction):
- Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits at index procedure.
- Successful delivery and deployment of the aortic stent graft and all modular stent graft components at index procedure
- Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels at final completion angiography.
- Absence of type I or type III endoleaks at final completion angiography.
- Patency of all aortic modular stent graft components and intended side branch components at final completion angiography.
Measured: Time of index procedure
Co-Primary Endpoint #2: Clinical Success
All of the following qualifying criteria are met from the initiation of the index procedure through 12 months post-index procedure:
- Technical success
- Absence of death from the initial procedure, secondary intervention, or aorta-related cause
- Absence of persistent type I or type III endoleak
- Absence of lesion enlargement >5 mm
- Absence of device migration >10 mm
- Absence of failure due to device integrity issues (defined as Grade 2 or 3 in Table 8)
- Absence of lesion rupture
- Absence of conversion to open surgical repair
- Absence of permanent paraplegia (see definition below)
- Absence of disabling stroke (see definition below)
- Absence of "loss of function" or "end-stage renal disease" stage according to the RIFLE Classification following the index procedure
Measured: Index procedure through 12 months
Secondary outcomes (15)
Target Vessel Technical Success
Successful catheterization and stent placement in all intended target vessels. Note: For this study, technical success will be reported for the overall procedure and specifically for the vessels targeted for treatment with the branch components (this "target vessel technical success" definition).
Measured: 30 days, 6 months, annually through 10 years
Secondary Clinical Success
Initial clinical success that is interrupted by a treatment failure and is successfully corrected with secondary reintervention (e.g., a patient undergoes a successful treatment of a type I, II, or III endoleak).
Measured: 30 days, 6 months, annually through 10 years
Assisted Primary Clinical Success
Clinical success that is obtained initially and continuously maintained with additional secondary reinterventions thus no interruption to initial clinical success.
Measured: 30 days, 6 months, annually through 10 years
Thirty-Day Mortality
Any death that occurs during the procedure, within the index procedure hospital stay, or within the first 30 days post-index procedure.
Measured: 30 days
Lesion-Related Mortality
Any death that occurs within the first 30 days, or any death that results from lesion rupture, aorta-related complications (e.g., infection, occlusion, dissection, hematoma), or a complication of a secondary intervention.
Measured: 30 days, 6 months, annually through 10 years
Major Adverse Events (MAEs)
Includes any of the following:
- All-cause mortality;
- Myocardial infarction resulting in severe hemodynamic dysfunction necessitating resuscitation, cardiac arrest, or fatal outcome;
- Respiratory failure requiring prolonged (>24 hours from anticipated) mechanical ventilation or reintubation;
- Renal function decline characterized by one or more of the following:
- >50% reduction in baseline Estimated Glomerular Filtration Rate (eGFR); or,
- New-onset dialysis;
- Bowel ischemia requiring surgical resection or not resolving with medical therapy;
- Permanent paraplegia (see "permanent paraplegia" definition below)
- Any major stroke
Measured: 30 days, 6 months, annually through 10 years
Secondary interventions
Any Reintervention: Any repeated vascular or nonvascular procedure on the index device (TAMBE Device or any stent or stent graft in contact with any TAMBE component).
- Note: Reintervention will be classified as "major", "minor", or "nonvascular" based on the definitions below.
Major Reintervention: Deployment of proximal or distal extensions, removal of the device, use of thrombectomy or thrombolysis, and any major open surgical procedure.
Minor Reintervention: Endovascular procedures (percutaneous transluminal angioplasty, atherectomy, stenting) without thrombectomy or thrombolysis, interventions to treat branch vessel stenosis, interventions to treat type II endoleaks or branch-related endoleaks, and minor surgical revisions (patch angioplasty) of the access vessels.
Nonvascular Reinterventions: Any reinterventions that would not be considered "major reintervention" or "minor reintervention" based on the above definitions.
Measured: Time of index procedure
Intraprocedural Complications
Any vessel perforation, dissection, or occlusion during target vessel cannulation and/or stenting.
Measured: 30 days, 6 months, annually through 10 years
Kink
Objective documentation of demonstrable angulation (localized angle of less than 90 degrees when measured along the centerline) in any of the stent components or native target vessel
Measured: 30 days, 6 months, annually through 10 years
Stenosis
Objective documentation of presence of narrowing with demonstrable flow in any of the components
Measured: 30 days, 6 months, annually through 10 years
Occlusion
Objective documentation of presence of complete stent occlusion with or without minimal flow into a targeted vessel.
Note: Occlusions will be stated if they occurred in the aortic component, in a branch component, or in a contralateral leg component used to treat the aortic disease.
Measured: 30 days, 6 months, annually through 10 years
Target Vessel Instability
Any death or rupture related to side branch complication (e.g., endoleak) or any secondary intervention indicated to treat a branch-related complication, including endoleak, disconnection, kink, stenosis, occlusion, or rupture.
Measured: 30 days, 6 months, annually through 10 years
Secondary Patency
Endovascular restoration of patency after occlusion of the side branch, stent, or stent graft has already occurred.
Note: Conversion to bypass or inability to treat by endovascular means defines loss of secondary patency.
Measured: 30 days, 6 months, annually through 10 years
Primary Assisted Patency
Endovascular intervention performed to maintain patency in the presence of stenosis before occlusion.
Measured: 30 days, 6 months, annually through 10 years
Primary Patency
Uninterrupted patency with no occlusion or procedure performed to maintain patency on the stent or native target vessel.
Note: Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency.
Measured: 30 days, 6 months, annually through 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start25 Nov 2024
- Primary completion25 Jun 2027 (estimated)
- Study completion1 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578741
- Sponsor's protocol ID
- AAA 24-01
- Status last verified
- Jul 2026
- First submitted
- 27 Aug 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
- ClinicalTrials.gov ID
- NCT06578741
- Acronym / sponsor ID
- AAA 24-01
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 310 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 25 Jun 2027 (estimated)
- Study completion
- 1 Jun 2036 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to confirm that the benefit-risk assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy of the TAMBE Device training program.
Detailed description
A maximum of 300 adult subjects will be enrolled at up to 60 U.S. centers, with a minimum of 70 subjects enrolled at study centers with no prior experience using the TAMBE Device. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 10 years post implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)Treatment with GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Treated with the aortic component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Aortic Component) to allow endovascular repair of an aortic disease involving the visceral vessels.
- Age ≥18 years at the time of informed consent signature.
- An Informed Consent Form signed by subject or legal representative.
Key exclusion criteria (4 listed)
- Any contraindications for the TAMBE Device according to the IFU.
- Planned parallel grafting with the TAMBE Aortic Component.
- Intent to modify TAMBE Aortic Component (e.g., in situ fenestration).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)Treatment with the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in patients with Pararenal Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms | Device | Single Arm |
Primary outcome
Co-Primary Endpoint #1: Technical Success
Time frame: Time of index procedure
All of the qualifying criteria are met (in the absence of surgical conversion or mortality, type I or type III endoleak, branch occlusion, or graft limb obstruction): * Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits at index procedure. * Successful delivery and deployment of the aortic stent graft and all modular stent graft components at index procedure * Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels at final completion angiography. * Absence of type I or type III endoleaks at final completion angiography. * Patency of all aortic modular stent graft components and intended side branch components at final completion angiography.
Co-Primary Endpoint #2: Clinical Success
Time frame: Index procedure through 12 months
All of the following qualifying criteria are met from the initiation of the index procedure through 12 months post-index procedure: * Technical success * Absence of death from the initial procedure, secondary intervention, or aorta-related cause * Absence of persistent type I or type III endoleak * Absence of lesion enlargement >5 mm * Absence of device migration >10 mm * Absence of failure due to device integrity issues (defined as Grade 2 or 3 in Table 8) * Absence of lesion rupture * Absence of conversion to open surgical repair * Absence of permanent paraplegia (see definition below) * Absence of disabling stroke (see definition below) * Absence of "loss of function" or "end-stage renal disease" stage according to the RIFLE Classification following the index procedure
15 secondary outcomes
Target Vessel Technical Success
Time frame: 30 days, 6 months, annually through 10 years
Secondary Clinical Success
Time frame: 30 days, 6 months, annually through 10 years
Assisted Primary Clinical Success
Time frame: 30 days, 6 months, annually through 10 years
Thirty-Day Mortality
Time frame: 30 days
Lesion-Related Mortality
Time frame: 30 days, 6 months, annually through 10 years
Major Adverse Events (MAEs)
Time frame: 30 days, 6 months, annually through 10 years
Secondary interventions
Time frame: Time of index procedure
Intraprocedural Complications
Time frame: 30 days, 6 months, annually through 10 years
Kink
Time frame: 30 days, 6 months, annually through 10 years
Stenosis
Time frame: 30 days, 6 months, annually through 10 years
Occlusion
Time frame: 30 days, 6 months, annually through 10 years
Target Vessel Instability
Time frame: 30 days, 6 months, annually through 10 years
Secondary Patency
Time frame: 30 days, 6 months, annually through 10 years
Primary Assisted Patency
Time frame: 30 days, 6 months, annually through 10 years
Primary Patency
Time frame: 30 days, 6 months, annually through 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in people with Abdominal Aortic Aneurysm and Pararenal Aortic Aneurysm, run by W.L.Gore & Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-Primary Endpoint #1: Technical Success (time frame: Time of index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.