Your session is about to expire
← Back to Search
Endovascular Device
GORE EXCLUDER Device for Aortic Aneurysm (TAMBE Trial)
N/A
Recruiting
Led By Mark Farber, MD
Research Sponsored by W.L.Gore & Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Age ≥ 19 years at the time of informed consent signature
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
TAMBE Trial Summary
This trial will compare two groups of people with similar aneurysms to see if one treatment is better than the other. One group will have just the TAMBE System, and the other group will have both the TAMBE System and the CTAG Device(s).
Who is the study for?
This trial is for adults over 19 with aortic aneurysms involving visceral vessels, who have suitable anatomy for the GORE EXCLUDER device. Candidates must not have had certain prior surgeries, infections, or conditions that would complicate the procedure or reduce life expectancy to under two years.Check my eligibility
What is being tested?
The study tests the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis in treating thoracoabdominal and pararenal aortic aneurysms. It's non-randomized with two arms: one focusing on just the TAMBE System and another combining it with CTAG Devices.See study design
What are the potential side effects?
While specific side effects are not listed here, endovascular procedures like this can generally lead to risks such as bleeding, infection at the access site, blood vessel damage, and potential complications related to device placement.
TAMBE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My aortic aneurysm extends close to my celiac artery and affects my abdominal aorta and at least one major artery.
Select...
I am 19 years old or older.
Select...
My aorta and related arteries fit the required sizes and conditions for the TAMBE Device.
Select...
I have a large or quickly growing aortic aneurysm needing treatment.
Select...
I am a man or a woman unable to have children.
Select...
My iliac arteries are suitable for surgery without needing special branch devices or artery blockage.
TAMBE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of Subjects free from Clinically Significant Reintervention / Lesion-Related Mortality Co-Primary Endpoint Events
Percent of Subjects with Uncomplicated Technical Success and freedom from Procedural Safety Composite Event
Secondary outcome measures
Length of Hospital Stay
Mean Procedural Blood Loss at Index Procedure
Percent of Subject with Thoracoabdominal Aneurysm (TAAA) Enlargement
+28 moreTAMBE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Secondary Study ArmExperimental Treatment1 Intervention
TAAA requiring TAMBE System and CTAG Device(s). Crawford Type I-III (n= 20 - 100)
Group II: Primary Study ArmActive Control1 Intervention
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
Find a Location
Who is running the clinical trial?
W.L.Gore & AssociatesLead Sponsor
95 Previous Clinical Trials
28,205 Total Patients Enrolled
1 Trials studying Thoracoabdominal Aortic Aneurysms
10 Patients Enrolled for Thoracoabdominal Aortic Aneurysms
Mark Farber, MDPrincipal InvestigatorUniversity of North Carolina
2 Previous Clinical Trials
559 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My aortic aneurysm extends close to my celiac artery and affects my abdominal aorta and at least one major artery.I am 19 years old or older.I have an infection that could risk a graft infection.You are not expected to live for more than 2 years.My kidney function is impaired, indicated by high creatinine, low GFR, or I am on dialysis.I have an aneurysm in my aorta that might need surgery within a year.You have a medical condition or body shape that makes it hard to see your aorta clearly with X-rays and CT scans.You have known allergies to the materials used in the device.My aortic aneurysm has burst or is leaking.My leg arteries are narrow or twisted, preventing standard vascular access.I have not had a heart attack or stroke in the last year.My aorta and related arteries fit the required sizes and conditions for the TAMBE Device.My aneurysm is suitable for a specific device placement according to its size and location.My aorta is enlarged because of a long-term tear.You have blood vessels with blockages, twists, or other problems that could make it difficult to insert the medical device or stop blood flow.I have a large or quickly growing aortic aneurysm needing treatment.I am a man or a woman unable to have children.My aorta is infected.You need to have suitable arteries in your body for the device to be placed.My iliac arteries are suitable for surgery without needing special branch devices or artery blockage.I have had open surgery on my aorta.My doctor prefers a less invasive treatment for my condition.You have had a bad reaction to heparin in the past.You have used drugs like cocaine, amphetamine, or alcohol in the past year.I have a condition like Marfan's or Ehler-Danlos Syndrome.I have an infection in the wall of my artery.
Research Study Groups:
This trial has the following groups:- Group 1: Primary Study Arm
- Group 2: Secondary Study Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants may be accepted into this trial?
"Affirmative. According to clinicaltrials.gov, this medical trial is actively recruiting participants who registered after June 17th 2019 and was last edited on August 19th 2022. In total, 122 individuals need to be enrolled across 42 sites in order for the study to reach completion."
Answered by AI
Are there opportunities to volunteer for this clinical investigation?
"According to information collated on clinicaltrials.gov, this medical research is actively enrolling participants; it was initially posted in June of 2019 and its latest update occurred in August 2022."
Answered by AI
Is there a concentration of medical centers administering this trial in North America?
"The study is being conducted at University of Michigan - Cardiac Surgery in Ann Arbor, MI, Cardiothoracic and Vascular Surgeons, PA (CTVS) in Austin, TX, and the University of Pennsylvania in Philadelphia. Additionally it has 42 more clinical trial centres dispersed across America."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger