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GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
N/A
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up index procedure through 12 months
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Abdominal Aortic Aneurysm
- Thoracoabdominal Aortic Aneurysms
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ index procedure through 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~index procedure through 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Co-Primary Endpoint #1: Technical Success
Co-Primary Endpoint #2: Clinical Success
Secondary study objectives
Assisted Primary Clinical Success
Intraprocedural Complications
Kink
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Treatment with GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)
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Who is running the clinical trial?
W.L.Gore & AssociatesLead Sponsor
100 Previous Clinical Trials
32,489 Total Patients Enrolled