Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
Phase: NA
Conditions: Aortic Aneurysm, Thoracic, Aorta; Lesion
Sponsor: W.L.Gore & Associates

 
GORE® TAG® Thoracic Branch Endoprosthesis  
MD143314 SSB 11-02 Protocol Revision# 10 Doc Type: SP 
CONFIDENTIAL INFORMATION 
MD133246 Protocol Template: Revision#: 2 
Doc Type: GC 
 
 
 
 
 
Nothing herein is to be disclosed in any way without the prior 
express written permission of W. L. Gore & Associates, Inc. 
 
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the 
Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta 
 
Protocol Number: 
 
SSB 11-02 
 
 
 
 
 
 
 
 
W. L. Gore & Associates, Inc. 
Medical Products Division 
 
23 Nov 2020 
 
 

 
GORE® TAG® Thoracic Branch Endoprosthesis 
MD143314 SSB 11-02 Protocol Revision# 10 Doc Type: SP 
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MD133246 Protocol Template: Revision#: 2 
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PROTOCOL SUMMARY 
Subjects enrolled on the SSB 11-02 Protocol prior to a site’s IRB approval of Revision 4 
should be followed under Revision 3 of the Protocol located in Appendix E (US only). 
Study Summary 
Study Title 
Evaluation of the GORE® TAG® Thoracic Branch 
Endoprosthesis (TBE Device) in the Treatment of Lesions of 
the Aortic Arch and Descending Thoracic Aorta 
Protocol Number 
SSB 11-02 
Revision  
10 
IDE or PMA Number  
G130120 
Sponsor 
W. L. Gore & Associates, Inc. 
Medical Products Division 
 
 
Sponsor (Japan) 
W. L. Gore & Associates G.K. 
Medical Products Division 
 
 
Study Design 
Prospective, non-randomized, multicenter study with four 
independent arms consisting of a total of seven cohorts: 
• 
Zone 2 – Aneurysm, hypothesis-driven analysis 
• 
Zone 2 – Non-aneurysm aortic lesions which are 
anatomically suitable for treatment with the TBE 
Device, descriptive analysis 
o Dissection cohort 
o Traumatic Transection cohort 
o Other isolated lesion types 
 
• 
Zone 0/1 – Aneurysm, hypothesis-driven analysis 
• 
Zone 0/1 – Non-aneurysm aortic lesions which are 
anatomically suitable for treatment with the TBE 
Device, descriptive analysis 
o Dissection cohort 
o Other isolated lesion types 
Study Objective 
Determine whether the GORE® TAG® Thoracic Branch 
Endoprosthesis is safe and effective in treating lesions of 
the aortic arch and descending thoracic aorta  
Study Endpoint(s) 
Primary Endpoint- Zone 2 Subjects (Aneurysm Cohort) 
Composite of the following events from the time of 
enrollment through one year: 
• 
Device Technical Success 
• 
Absence of the following: 
o Aortic rupture; 
o Lesion-related mortality; 

 
GORE® TAG® Thoracic Branch Endoprosthesis 
MD143314 SSB 11-02 Protocol Revision# 10 Doc Type: SP 
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o Disabling stroke; 
o Permanent paraplegia; 
o Permanent paraparesis;  
o New onset renal failure requiring permanent 
dialysis; 
o Additional unanticipated post-procedural 
surgical or interventional procedure related to 
the device, procedure, or withdrawal of the 
delivery system. 
 
Primary Endpoint- Zone 0/1 Subjects (Aneurysm Cohort) 
Composite of the following events from time of enrollment 
through one month following endovascular procedure: 
• 
Initiation of the index endovascular procedure 
following the debranching procedure  
• 
Device Technical Success for the index 
endovascular procedure 
• 
Absence of the following: 
o Aortic rupture; 
o Lesion-related mortality; 
o Disabling stroke; 
o Permanent paraplegia; 
o Permanent paraparesis; 
o New onset renal failure requiring permanent 
dialysis; 
o Additional unanticipated post-procedural 
surgical or interventional procedure related to 
the device, procedure, or withdrawal of the 
delivery system. 
Subject Population 
Subjects with thoracic aortic lesions which require coverage 
of the left subclavian artery, left common carotid artery 
and/or the brachiocephalic trunk/innominate artery for 
effective treatment. 
Number of Subjects 
Total Enrollment of 175-465 Subjects across four 
independent arms with a total of seven cohorts as follows: 
• 
Zone 2 – Aortic Aneurysm; A maximum of 115 
Subjects 
o Primary Enrollment (n=85 Subjects) 
o Continued Access Enrollment (maximum 30 
Subjects) 
• 
Zone 2 – Non-aneurysm aortic lesions; A maximum 
of 200 Subjects in all cohorts combined. 
o Dissection cohort (minimum 20 Subjects) 
o Traumatic Transection cohort (minimum 10 
Subjects) 
o Other isolated lesion types 
• 
Zone 0/1 – Aortic Aneurysm; 50 Subjects 
• 
Zone 0/1 – Non-aneurysm aortic lesions; A 
maximum of 100 Subjects in all cohorts combined.  

 
GORE® TAG® Thoracic Branch Endoprosthesis 
MD143314 SSB 11-02 Protocol Revision# 10 Doc Type: SP 
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MD133246 Protocol Template: Revision#: 2 
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o Dissection cohort (minimum 10 Subjects) 
o Other isolated lesion types 
Number of Sites 
Up to 40 sites in the U.S. (Zone 2 and Zone 0/1) and up to 5 
sites in Japan (Zone 0/1). 
Coordination PI 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Expected Time to 
Complete Enrollment  
• 
Zone 2 - Aortic Aneurysm Subject accrual: 18-24 
months  
• 
Zone 0/1 - Aortic Aneurysm Subject accrual: 48-60 
months  
• 
Follow-up – Five years from treatment date Total 
study duration –Ten years  
Schedule of Events 
Zone 2 Cohorts 
Screening Evaluation: 
(Within 30 days prior to enrollment unless otherwise noted)  
• 
Physical examination, medical history 
• 
Modified Rankin Scale 
• 
Spinal Cord Ischemia Scale 
• 
NIH Stroke Scale 
• 
Spiral Computed Tomographic Angiography (CTA) of 
the chest, abdomen, and pelvis (contrast only) within 
90 days prior to enrollment 
• 
Serum creatinine concentration 
 
Procedure: 
• 
Endovascular repair with the TBE Device with distal 
extension using the Conformable GORE® TAG® 
Thoracic Endoprosthesis as needed  
• 
Post deployment angiogram  
 
Post Procedure: 
(Performed prior to discharge unless otherwise noted) 
• 
Physical examination  
• 
Modified Rankin Scale 
• 
Spinal Cord Ischemia Scale 

 
GORE® TAG® Thoracic Branch Endoprosthesis 
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• 
NIH Stroke Scale  
• 
In addition, NIH Stroke Scale should be performed 
for any Subject suspected of having a stroke event 
that undergoes the treating site’s stroke Protocol 
during the study interval from the initiation of index 
endovascular procedure until discharge, and should 
be performed as soon as possible after learning of 
the event  
 
Follow-Up Evaluations: 
Intervals: 1, 6, 12, 24, 36, 48, and 60 months post-treatment 
• 
Physical examination 
• 
Modified Rankin Scale (also completed at 3 months 
for Subjects suspected of experiencing a stroke 
event through 30 days) 
• 
Spinal Cord Ischemia Scale  
• 
Spiral CTA of the chest (contrast) 
• 
NIH Stroke Scale (one month only) 
• 
Dissection Subjects only: Spiral CTA of the chest, 
abdomen, and pelvis (contrast) 
• 
Spiral CT of the chest (non-contrast - one month 
only, or if endoleak suspected) 
• 
Dissection Subjects only: Spiral CTA of the chest, 
abdomen, and pelvis (non-contrast - one month only, 
or if endoleak suspected) 
Schedule of Events 
Zone 0/1 Cohorts 
Screening Evaluation: 
(Within 30 days prior to enrollment unless otherwise noted)  
• 
Physical examination, medical history 
• 
Modified Rankin Scale 
• 
Spinal Cord Ischemia Scale 
• 
NIH Stroke Scale 
• 
Serum creatinine concentration 
• 
Spiral Computed Tomographic Angiography (CTA) of 
the chest, abdomen, and pelvis (contrast only) within 
90 days prior to the Phase 2 procedure 
• 
Radiological Evaluation of the Head/Neck within 90 
days prior to Phase 1 procedure 
 
Phase 1 Evaluation at least 24 hours but no more than 60 
days following the completion of the revascularization 
procedure: 
• 
Physical examination  
• 
Modified Rankin Scale 
• 
Spinal Cord Ischemia Scale 
• 
In addition, NIH Stroke Scale should be performed 
for any Subject suspected of having a stroke event 
that undergoes the treating site’s stroke Protocol 
during the study interval from the initiation of surgical 

 
GORE® TAG® Thoracic Branch Endoprosthesis 
MD143314 SSB 11-02 Protocol Revision# 10 Doc Type: SP 
CONFIDENTIAL INFORMATION                        
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MD133246 Protocol Template: Revision#: 2 
Doc Type: GC 
revascularization procedure until discharge post-
index endovascular procedure, and it should be 
performed as soon as possible after learning of the 
event 
 
Phase 2 Procedure at least 24 hours but no more than 60 
days following the completion of the revascularization 
procedure: 
• 
Endovascular repair with the TBE Device  
• 
Post deployment angiogram 
   
 
Post Procedure: 
(Performed prior to discharge unless otherwise noted) 
• 
Physical examination  
• 
Modified Rankin Scale  
• 
Spinal Cord Ischemia Scale  
• 
NIH Stroke Scale  
• 
In addition, NIH Stroke Scale should be performed 
for any Subject suspected of having a stroke event 
that undergoes the treating site’s stroke Protocol 
during the study interval from the initiation of surgical 
revascularization procedure until discharge post-
index endovascular procedure, and it should be 
performed as soon as possible after learning of the 
event  
Follow-Up Evaluations: 
Intervals: 1, 6, 12, 24, 36, 48, and 60 months post-treatment 
• 
Physical examination 
• 
Modified Rankin Scale (also completed at 3 months 
for Subjects suspected of experiencing a stroke 
event through 30 days) 
• 
Spinal Cord Ischemia Scale 
• 
NIH Stroke Scale (one month only) 
• 
Spiral CTA of the chest (contrast) 
• 
Dissection Subjects only: Spiral CTA of the chest, 
abdomen and pelvis (contrast) 
• 
Spiral CT of the chest (non-contrast – one month 
only, or if endoleak suspected) 
• 
Dissection Subjects only: Spiral CTA of the chest, 
abdomen and pelvis (non-contrast – one month only, 
or if endoleak suspected) 

 
GORE® TAG® Thoracic Branch Endoprosthesis 
MD143314 SSB 11-02 Protocol Revision# 10 Doc Type: SP 
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MD133246 Protocol Template: Revision#: 2 
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Additional Information