GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms (TAMBE)
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ClinicalTrials.gov Identifier: NCT02528500 |
Recruitment Status :
Completed
First Posted : August 19, 2015
Results First Posted : July 3, 2018
Last Update Posted : June 28, 2023
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Thoracoabdominal Aortic Aneurysm |
Intervention |
Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis |
Enrollment | 10 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | TAMBE Device |
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Arm/Group Description |
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. GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis: Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) |
Period Title: Overall Study | |
Started | 10 |
Completed | 10 |
Not Completed | 0 |
Arm/Group Title | TAMBE Device | |
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Arm/Group Description |
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. GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis: Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) |
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Overall Number of Baseline Participants | 10 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 10 participants | |
70.2 (7.13) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | |
Female |
1 10.0%
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Male |
9 90.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | |
Hispanic or Latino |
0 0.0%
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Not Hispanic or Latino |
7 70.0%
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Unknown or Not Reported |
3 30.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
10 100.0%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Height
Mean (Standard Deviation) Unit of measure: Centimeters (cm) |
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Number Analyzed | 10 participants | |
174.1 (9.72) | ||
Weight
Mean (Standard Deviation) Unit of measure: Kilograms (kg) |
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Number Analyzed | 10 participants | |
86.4 (20.6) | ||
Body Mass Index (BMI)
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 10 participants | |
28.2 (5.07) |
Name/Title: | Rimma Zakharyan |
Organization: | W. L. Gore & Associates |
Phone: | 928 310 6961 |
EMail: | rzakhary@wlgore.com |
Responsible Party: | W.L.Gore & Associates |
ClinicalTrials.gov Identifier: | NCT02528500 |
Other Study ID Numbers: |
AAA 13-02 |
First Submitted: | August 17, 2015 |
First Posted: | August 19, 2015 |
Results First Submitted: | June 4, 2018 |
Results First Posted: | July 3, 2018 |
Last Update Posted: | June 28, 2023 |