GORE® EXCLUDER® Device for Thoracoabdominal Conditions
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)
Aortic Aneurysm, Thoracoabdominal+4
+ Aneurysm
+ Aortic Aneurysm
Treatment Study
Summary
Study start date: November 25, 2024
Actual date on which the first participant was enrolled.This study is focused on evaluating a medical device called the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis, which is used in treating complex aortic aneurysms. Aortic aneurysms occur when a bulge forms in the wall of the aorta, the largest artery in the body, and can be life-threatening if not properly managed. The study aims to enroll up to 300 adults across various U.S. centers, particularly emphasizing those sites without previous experience with this device. The goal is to better understand the device's long-term effectiveness and safety, potentially improving treatment options for patients with this serious condition. Participants in the study will undergo a procedure to have the GORE® EXCLUDER® device implanted. This device is used to support the aorta and prevent the aneurysm from causing further harm. After the procedure, participants will be monitored closely at specific intervals: one month, six months, twelve months, and then every year for up to ten years after the implant. This regular follow-up helps researchers gather detailed information on how well the device performs over time and ensures any potential issues are spotted early. The study does not specify any immediate risks or benefits, but the extended monitoring aims to ensure patient safety and device reliability.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: The subject is / has: 1. Treated with the aortic component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Aortic Component) to allow endovascular repair of an aortic disease involving the visceral vessels. 2. Age ≥18 years at the time of informed consent signature. 3. An Informed Consent Form signed by subject or legal representative. Exclusion Criteria: The subject is / has: 1. Any contraindications for the TAMBE Device according to the IFU. 2. Planned parallel grafting with the TAMBE Aortic Component. 3. Intent to modify TAMBE Aortic Component (e.g., in situ fenestration).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location