Thoracoabdominal Aortic AneurysmTAMBENCT02528500
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms
A study testing GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in people with Thoracoabdominal Aortic Aneurysm, run by W.L.Gore & Associates at 6 sites in United States.
Trial summary
This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm
- What is being tested?
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2015to Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Aortic aneurysm involving the visceral vessels requiring treatment
- Adequate access for TAMBE Device components
- Appropriate aortic anatomy to receive the TAMBE Device
- Age ≥ 18 years at the time of informed consent signature
- Male or infertile female
- The patient is considered high risk for open 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 Note: Additional Inclusion Criteria may apply
Who cannot join
- Prior aortic surgery
- Ruptured or leaking aortic aneurysm
- Aneurysmal dilatation due to chronic aortic dissection
- Infected aorta
- Mycotic aneurysm
- Life expectancy <2 years
Show all 16Show fewer
- Myocardial infarction or stroke within 6 weeks of treatment
- Systemic infection which may increase risk of endovascular graft infection
- Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
- Participation in another drug or medical device study within 1 year of study enrollment
- 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
- Known sensitivities or allergies to the device materials
- 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 Note: Additional Exclusion Criteria may apply
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
The Mount Sinai Medical Center
New York, New York, 10029
UPMC
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Early Feasibility Assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms Involving the Visceral Branch Vessels
This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.
Read the detailed description
This is a prospective, non-randomized study designed to assess the feasibility of the TAMBE Device in the treatment of patients with aortic aneurysms involving the visceral branch vessels. A maximum of 10 Subjects will be treated under this Protocol. This clinical study will include up to six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, contrast-enhanced computed tomography (CT) of chest, abdomen and pelvis, creatinine measurement, abdominal ultrasound (optional) at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis implant.
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Being tested
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
- Medical subject headings
- 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 EndoprosthesisDevice
Also called TAMBE Device
Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)
| Study group | Role | What they receive |
|---|---|---|
| TAMBE Device | Experimental | Study designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled. Receives: Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL
Absence of the following procedural safety events through 30 days post-procedure: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL
Measured: Absence of procedural safety events through 30 days post procedure
Secondary outcomes (4)
Technical Success, Including Individual Components of Technical Success
Components of Technical Success: Successful access to the necessary arterial sites, successful deployment of all required TAMBE Device components, Patency of all required TAMBE Device components and any required accessory components on completion angiography, absence of surgical conversion within 24 hours of initial of procedure
Measured: 12-month
Device Integrity, Including Individual Components of Device Integrity
Components of Device Integrity: Loss of functional patency in any treated branch component due to thrombus or mechanical failure of branch component, loss of functional patency in main body component(s) due to thrombus or mechanical failure of main body components(s) , separation of treated branch component from the main body component(s), separation of the main body component(s) from the accessory components
Measured: 12-month
Patency (Primary, Assisted Primary, and Secondary)
Primary Patency - Blood flow without occlusion maintained through the device without an intervention. Assisted Primary Patency: Blood flow maintained through the device after implant regardless of re-interventions performed. Secondary Patency - Blood flow through the device (following occlusion) regardless of re-interventions performed and freedom from surgical bypass.
Measured: 12-month
Absence of Type I and Type III Endoleaks at One Month Follow-up
Absence of Type I and Type III endoleaks
Measured: One Month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionFeb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracoabdominal 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel Makaroun, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528500
- Sponsor's protocol ID
- AAA 13-02
- Acronym
- TAMBE
- Status last verified
- Jun 2023
- First submitted
- 17 Aug 2015
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Oderich GS, Farber MA, Silveira PG, Tadros R, Marin M, Fillinger M, Makaroun M, Hemmer J, Madden M. Technical aspects and 30-day outcomes of the prospective early feasibility study of the GORE EXCLUDER Thoracoabdominal Branched Endoprosthesis (TAMBE) to treat pararenal and extent IV thoracoabdominal aortic aneurysms. J Vasc Surg. 2019 Aug;70(2):358-368.e6. doi: 10.1016/j.jvs.2018.10.103. Epub 2019 Jan 3.
PubMed 30612825
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms Involving the Visceral Branch Vessels
- ClinicalTrials.gov ID
- NCT02528500
- Acronym / sponsor ID
- TAMBE / AAA 13-02
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Feb 2023 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Posted 3 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.
Detailed description
This is a prospective, non-randomized study designed to assess the feasibility of the TAMBE Device in the treatment of patients with aortic aneurysms involving the visceral branch vessels. A maximum of 10 Subjects will be treated under this Protocol. This clinical study will include up to six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, contrast-enhanced computed tomography (CT) of chest, abdomen and pelvis, creatinine measurement, abdominal ultrasound (optional) at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAMBE Device | Experimental | Device: GORE® EXCLUDER® Thoracoabdominal Branch EndoprosthesisStudy designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aortic aneurysm involving the visceral vessels requiring treatment
- Adequate access for TAMBE Device components
- Appropriate aortic anatomy to receive the TAMBE Device
- Age ≥ 18 years at the time of informed consent signature
- Male or infertile female
Key exclusion criteria (16 listed)
- Prior aortic surgery
- Ruptured or leaking aortic aneurysm
- Aneurysmal dilatation due to chronic aortic dissection
- Infected aorta
- Mycotic aneurysm
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 EndoprosthesisAlso: TAMBE DeviceNon-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) | Device | TAMBE Device |
Primary outcome
Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL
Time frame: Absence of procedural safety events through 30 days post procedure
Absence of the following procedural safety events through 30 days post-procedure: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL
4 secondary outcomes
Technical Success, Including Individual Components of Technical Success
Time frame: 12-month
Device Integrity, Including Individual Components of Device Integrity
Time frame: 12-month
Patency (Primary, Assisted Primary, and Secondary)
Time frame: 12-month
Absence of Type I and Type III Endoleaks at One Month Follow-up
Time frame: One Month followup
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30612825Oderich GS, Farber MA, Silveira PG, Tadros R, Marin M, Fillinger M, Makaroun M, Hemmer J, Madden M. Technical aspects and 30-day outcomes of the prospective early feasibility study of the GORE EXCLUDER Thoracoabdominal Branched Endoprosthesis (TAMBE) to treat pararenal and extent IV thoracoabdominal aortic aneurysms. J Vasc Surg. 2019 Aug;70(2):358-368.e6. doi: 10.1016/j.jvs.2018.10.103. Epub 2019 Jan 3.
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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.
Michel Makaroun, M.D. principal investigator
University of Pittsburgh
6 sites 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 in people with Thoracoabdominal Aortic Aneurysm, run by W.L.Gore & Associates at 6 sites 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 8 inclusion and 16 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: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Yes. Results are posted in the registry (first posted 3 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL (time frame: Absence of procedural safety events through 30 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02528500, which also lists 1 linked publication.
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 28 Jun 2023.