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Endoprosthesis

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis for Thoracoabdominal Aortic Aneurysms (TAMBE Trial)

N/A

Waitlist Available

Led By Michel Makaroun, M.D.

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 one month followup

Awards & highlights

TAMBE Trial Summary

This trial will test a new device to see if it can treat aortic aneurysms that involve the visceral branch vessels.

Eligible Conditions

Thoracoabdominal Aortic Aneurysms

TAMBE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL

Secondary outcome measures

Absence of Type I and Type III Endoleaks at One Month Follow-up

Device Integrity, Including Individual Components of Device Integrity

Patency (Primary, Assisted Primary, and Secondary)

+1 more

TAMBE Trial Design

1Treatment groups

Experimental Treatment

Group I: TAMBE DeviceExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

2015

N/A

~10

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Find a Location

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor

95 Previous Clinical Trials

28,317 Total Patients Enrolled

1 Trials studying Thoracoabdominal Aortic Aneurysms

122 Patients Enrolled for Thoracoabdominal Aortic Aneurysms

Michel Makaroun, M.D.Principal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities to join the research?

"Clinicaltrials.gov reveals that this medical trial is currently unable to accept new participants. Initially appearing on November 1st 2015 and last updated on February 28th 2022, the research in question does not have any current openings; however, there are other trials actively recruiting with a total of 152 available positions at present."

Answered by AI

Are there a significant number of venues conducting this research within the United States?

"The Mount Sinai Medical Center, Mayo Clinic in Rochester, Dartmouth-Hitchcock Medical Centre, and 6 other medical centres are facilitating the clinical trial."

Answered by AI

Recent research and studies

Journal of Vascular SurgeryJournal

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

Oderich, Gustavo S., Mark A. Farber, Pierre Galvagni Silveira, Rami Tadros, Michael Marin, Mark Fillinger, Michel Makaroun, Jason Hemmer, and Meghan Madden. 2019. “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”. Journal of Vascular Surgery. Elsevier BV. doi:10.1016/j.jvs.2018.10.103.

clinicaltrials.govStudy

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms

2015. "GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02528500.