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Endovascular Device

GORE EXCLUDER Device for Aortic Aneurysm (TAMBE Trial)

New York, NY
N/A
Waitlist Available
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
Must not have
Systemic infection which may increase risk of endovascular graft infection
Renal Insufficiency (creatinine value > 1.8 mg/dL, GFR < 30, or patient undergoing dialysis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

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).

See full description
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My aortic aneurysm extends close to my celiac artery and affects my abdominal aorta and at least one major artery.
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I am 19 years old or older.
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My aorta and related arteries fit the required sizes and conditions for the TAMBE Device.
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I have a large or quickly growing aortic aneurysm needing treatment.
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I am a man or a woman unable to have children.
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My iliac arteries are suitable for surgery without needing special branch devices or artery blockage.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an infection that could risk a graft infection.
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My kidney function is impaired, indicated by high creatinine, low GFR, or I am on dialysis.
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I have an aneurysm in my aorta that might need surgery within a year.
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My aortic aneurysm has burst or is leaking.
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My leg arteries are narrow or twisted, preventing standard vascular access.
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My aorta is enlarged because of a long-term tear.
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My aorta is infected.
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I have had open surgery on my aorta.
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I have a condition like Marfan's or Ehler-Danlos Syndrome.
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I have an infection in the wall of my artery.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Secondary study objectives
Percent of Subject With Thoracoabdominal Aneurysm (TAAA) Enlargement
Percent of Subjects With Acute Kidney Injury
Percent of Subjects With Device Migration
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Closest Location:The Ohio State University Wexner Medical Center· Columbus, OH· 4 miles

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor
102 Previous Clinical Trials
32,809 Total Patients Enrolled
Mark Farber, MDPrincipal InvestigatorUniversity of North Carolina
2 Previous Clinical Trials
559 Total Patients Enrolled

Media Library

GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (Endovascular Device) Clinical Trial Eligibility Overview. Trial Name: NCT03728985 — N/A
Thoracoabdominal Aortic Aneurysms Research Study Groups: Primary Study Arm, Secondary Study Arm
Thoracoabdominal Aortic Aneurysms Clinical Trial 2023: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Highlights & Side Effects. Trial Name: NCT03728985 — N/A
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (Endovascular Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03728985 — N/A
~15 spots leftby Mar 2026
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