Early Feasibility Assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms Involving the Visceral Branch Vessels
Phase: NA
Conditions: Thoracoabdominal Aortic Aneurysm
Sponsor: W.L.Gore & Associates

 
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis 
 
MD134357 AAA 13-02 Protocol Revision # 2 Doc Type SP 
CONFIDENTIAL INFORMATION 
TMPLT 11-11-14 Prot APP.doc 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol Summary 
 
Study Acronym/Protocol #: AAA 13-02 
06 Dec 2017 
 
NCT02528500 

 
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis 
 
MD134357 AAA 13-02 Protocol Revision # 2 Doc Type SP 
CONFIDENTIAL INFORMATION 
TMPLT 11-11-14 Prot APP.doc 
 
PROTOCOL SUMMARY 
Study Title 
Early Feasibility Assessment of the GORE® EXCLUDER® Thoracoabdominal 
Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic 
Aneurysms Involving the Visceral Branch Vessels 
Protocol Number 
AAA 13-02 
Sponsor 
W. L. Gore & Associates, Inc.  
Medical Products Division 
Telephone: 800-437-8181 
Study Design 
This is a non-randomized, multicenter study designed to assess the initial 
feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch 
Endoprosthesis (TAMBE Device) 
Study Objective 
Assess the initial safety of the TAMBE Device implantation procedure in the 
treatment of Aortic Aneurysms Involving the Visceral Branch Vessels 
Study Rationale 
This study is designed to provide evidence to support the use of the TAMBE 
Device as an option for endovascular treatment of patients with Type IV 
Thoracoabdominal Aortic Aneurysms. 
Study Endpoints 
Primary endpoint:  
Procedural Safety - Absence of the following events through 30 days post-
procedure: 
• 
Death 
• 
Stroke 
• 
Myocardial Infarction 
• 
Bowel Ischemia 
• 
Paraplegia 
• 
Respiratory Failure 
• 
Renal Failure  
• 
Procedural Blood Loss ≥1000 mL  
Secondary endpoints: 
Technical Success - All of the following: 
• 
Successful access to the necessary arterial sites  
• 
Successful deployment of all required TAMBE Device components 
and any required accessory components 
• 
Patency of all required TAMBE Device components and any required 
accessory components on completion angiography 
• 
Absence of surgical conversion within 24 hours of initiation of the 
procedure  

 
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis 
 
MD134357 AAA 13-02 Protocol Revision # 2 Doc Type SP 
CONFIDENTIAL INFORMATION 
TMPLT 11-11-14 Prot APP.doc 
 
Device integrity - Absence of the following events through one year of follow-
up: 
• 
Loss of functional patency in any branch component due to thrombus 
or mechanical failure of the branch components 
• 
Loss of functional patency in the main body component(s) due to 
thrombus or mechanical failure of the main body component(s) 
• 
Separation of the branch components from the main body 
component(s) 
• 
Separation of the main body component(s) from the accessory 
components (Distal Bifurcated Component and / or contralateral limb 
components) 
 
Individual components of technical success 
Individual components of device integrity at one month, six months and 
one year follow-up 
Patency (Primary, Assisted Primary and Secondary) 
Absence of Type I and Type III endoleaks at one month follow-up 
 
Subject Population 
Subjects with Thoracoabdominal Aortic Aneurysms Involving the Visceral 
Branch Vessels 
Number of Subjects 
Treated 
10  
Number of Sites 
Six in the United States 
Expected Time to 
Complete Enrollment  
18 Months 
Schedule of Events 
Assessments at Pre-treatment: 
• 
CT of chest, abdomen and pelvis 
• 
Physical exam 
• 
Creatinine measurement 
Assessments at Treatment: 
• 
Angiography 
Assessments at Hospital Discharge: 
• 
Physical exam 
• 
Creatinine measurement 
• 
Abdominal ultrasound (optional) 
Assessments at Follow-up (One month, six months, and annually 
through 5 years): 
• 
CT of chest, abdomen and pelvis (not required at hospital discharge) 
• 
Lumbar spine series X-ray (4 views) (annual follow-up only)* 
• 
Physical exam 
• 
Creatinine measurement 
• 
Abdominal ultrasound (optional) 
*As enrollment is closed for this study, for all subjects that have completed their one 
year follow-up prior to this protocol amendment being implemented, subjects will be 

 
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis 
 
MD134357 AAA 13-02 Protocol Revision # 2 Doc Type SP 
CONFIDENTIAL INFORMATION 
TMPLT 11-11-14 Prot APP.doc 
 
expected to have radiograph assessments at their next annual follow-up exam (i.e. 
two year follow-up) and annually thereafter. 
Anticipated Total Study 
Duration 
7 years from initiation of enrollment