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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02528500
Recruitment Status : Active, not recruiting
First Posted : August 19, 2015
Results First Posted : July 3, 2018
Last Update Posted : September 15, 2021
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Type Interventional
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
Hide 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
Hide 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)

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
70.2  (7.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
1
  10.0%
Male
9
  90.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
7
  70.0%
Unknown or Not Reported
3
  30.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 10 participants
174.1  (9.72)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 10 participants
86.4  (20.6)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 10 participants
28.2  (5.07)
1.Primary Outcome
Title Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL
Hide Description Absence of the following procedural safety events through 30 days post-procedure: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL
Time Frame Absence of procedural safety events through 30 days post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TAMBE Device
Hide 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)

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
9
  90.0%
2.Secondary Outcome
Title Technical Success, Including Individual Components of Technical Success
Hide Description Components of Technical Success: Successful access to the necessary arterial sites, successful deployment of all required TAMBE Device components, Patency of all required TAMBE Device components and any required accessory components on completion angiography, absence of surgical conversion within 24 hours of initial of procedure
Time Frame Ongoing thoughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Device Integrity, Including Individual Components of Device Integrity
Hide Description Components of Device Integrity: Loss of functional patency in any treated branch component due to thrombus or mechanical failure of branch component, loss of functional patency in main body component(s) due to thrombus or mechanical failure of main body components(s) , separation of treated branch component from the main body component(s), separation of the main body component(s) from the accessory components
Time Frame Ongoing thoughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Patency (Primary, Assisted Primary, and Secondary)
Hide Description Primary Patency - Blood flow without occlusion maintained through the device without an intervention. Assisted Primary Patency: Blood flow maintained through the device after implant regardless of re-interventions performed. Secondary Patency - Blood flow through the device (following occlusion) regardless of re-interventions performed and freedom from surgical bypass.
Time Frame Ongoing thoughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Absence of Type I and Type III Endoleaks at One Month Follow-up
Hide Description Absence of Type I and Type III endoleaks
Time Frame One Month followup
Outcome Measure Data Not Reported
Time Frame 1 Year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TAMBE Device
Hide 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)

All-Cause Mortality
TAMBE Device
Affected / at Risk (%)
Total   1/10 (10.00%)    
Hide Serious Adverse Events
TAMBE Device
Affected / at Risk (%) # Events
Total   5/10 (50.00%)    
Cardiac disorders   
Cardiac failure congestive  1  1/10 (10.00%)  1
Acute myocardial infarction  1  1/10 (10.00%)  1
Gastrointestinal disorders   
Diarrhoea  1  1/10 (10.00%)  1
Illeus  1  1/10 (10.00%)  1
General disorders   
Vascular stent stenosis  1  1/10 (10.00%)  1
Vascular stent occlusion  1  1/10 (10.00%)  1
Hepatobiliary disorders   
Cholecystitis acute  1  1/10 (10.00%)  1
Infections and infestations   
Pyelonephritis  1  1/10 (10.00%)  1
Nervous system disorders   
Spinal claudication  1  1/10 (10.00%)  1
Renal and urinary disorders   
Acute kidney injury  1  1/10 (10.00%)  1
Renal artery occlusion  1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/10 (10.00%)  1
Vascular disorders   
Artery dissection  1  1/10 (10.00%)  1
Arterial stenosis  1  1/10 (10.00%)  1
1
Term from vocabulary, MedDRA V21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TAMBE Device
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Cardiac disorders   
Acute myocardial infarction  1  1/10 (10.00%)  1
Ventricular dyssynchrony  1  1/10 (10.00%)  1
Sinus bradycardia  1  1/10 (10.00%)  1
Gastrointestinal disorders   
Colitis ischaemic  1  1/10 (10.00%)  1
Constipation  1  1/10 (10.00%)  1
Ileus paralytic  1  1/10 (10.00%)  1
General disorders   
Pyrexia  1  1/10 (10.00%)  1
Stent-graft endoleak  1  2/10 (20.00%)  3
Infections and infestations   
Pneumonia  1  1/10 (10.00%)  1
Septic Shock  1  1/10 (10.00%)  1
Urinary tract infection  1  1/10 (10.00%)  1
Injury, poisoning and procedural complications   
Facial bones fracture  1  1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  3/10 (30.00%)  3
Musculoskeletal pain  1  1/10 (10.00%)  1
Pain in extremity  1  2/10 (20.00%)  2
Nervous system disorders   
Hypersomnia  1  1/10 (10.00%)  1
Cerebrospinal fluid leakage  1  1/10 (10.00%)  1
Hypoaesthesia  1  3/10 (30.00%)  3
Seizure  1  1/10 (10.00%)  1
Renal and urinary disorders   
Urinary retention  1  1/10 (10.00%)  1
Acute kidney injury  1  2/10 (20.00%)  2
Renal infarct  1  1/10 (10.00%)  1
Haematuria  1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  1/10 (10.00%)  1
Vascular disorders   
Peripheral artery thrombosis  1  1/10 (10.00%)  1
1
Term from vocabulary, MedDRA V21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Institution and Investigator agree not to submit any Publication until Study Completion and multi-center Publication has been published. If the multi-center Publication has not been submitted within 12 months of Study Completion, Institution and investigator may proceed with submission of the Publication; subject to the following: Investigator will provide all Publications to Sponsor for review that is more than 60 days but may extend an additional 120 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Justine Roberts
Organization: W. L. Gore & Associates
Phone: 928-864-3349
EMail: jusrober@wlgore.com
Layout table for additonal information
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: September 15, 2021