Observational Registry Characterizing the Performance and Feature Use of the GORE® TAG® Conformable Thoracic Stent Graft Featuring ACTIVE CONTROL System
Conditions: Thoracic Diseases
Sponsor: W.L.Gore & Associates

GORE® TAG
® Conformable Thoracic Stent Graft with ACTIVE CONTROL 
 TAG 15-03 Protocol Revision#: 2 Doc Type: SP 
 
 
 
Nothing herein is to be disclosed in any way without the prior express written permission 
of W. L. Gore & Associates, Inc. 
 
 
 
 
 
 
 
 
Observational Registry Characterizing the Performance and Feature Use of the GORE® TAG
® 
Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System  
 
 
Protocol Number: TAG 15-03 
 
 
 
 
Amendment 1 
 
 
 
 
 
W. L. Gore & Associates, Inc. 
Medical Products Division 
 
 
Version: revision #2
Approval date: 04/27/2017
NCT number: NCT03286400

 
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PROTOCOL SUMMARY 
 
 
Registry Title 
Observational Registry Characterizing the Performance and Feature Use of 
the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE 
CONTROL System  
Short Title 
SURPASS 
Protocol Number 
TAG 15-03 
Sponsor 
W. L. Gore & Associates, Inc. 
Medical Products Division 
3450 W. Kiltie Lane 
Flagstaff, AZ 86005 
United States 
Telephone: +1 800-437-8181 
Registry Design 
Observational, prospective, single-arm, post-market registry  
Registry Objective 
Collect real-world clinical and device-specific outcomes of the GORE® TAG® 
Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System 
(CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as 
part of routine clinical practice.  
Registry Endpoint(s) 
Primary Endpoints:  
1.  Procedural technical success
 
 
 
 
 
 
 
 
 
 
 
 
2.  Treatment Success at thirty (30) days defined as technical success and 
freedom from: 
 
 
 
 
 
 
 
 

 
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Secondary Endpoints:  
1.  Freedom from the following Major Adverse Events (MAEs) through 12 
months, described individually at the 30-day and 12-month visits: 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
2.  Treatment Success at 12 months as defined as technical success and 
freedom from: 
 
 
 
 
 
 
 
 
3.  Freedom from the incidence of SAEs, other than MAEs, throughout the 
registry duration 
4.  Measures of Pathology-specific remodeling: 
 
 
 
  
 
     
  
Patient Population 
Patients treated with the GORE® TAG
® Conformable Thoracic Stent Graft 
featuring ACTIVE CONTROL System for diseases of the thoracic aorta 
Selection Criteria 
Inclusion criteria 
 Age  ≥ 18 years 
  Signed informed consent form 
  Willingness to adhere to standard of care follow-up requirements 
  Surgical indication for TEVAR based on Investigator’s best medical 
judgment 
  Intent to treat with CTAG Device with ACTIVE CONTROL. 
Exclusion criteria 
  Paraplegia or paraparesis at initial presentation 
  Participation in concurrent research study or registry which may 
confound registry results, unless approved by Sponsor 
  Prior implantation of a thoracic stent graft  

 
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  Pregnant or breast-feeding female at time of informed consent 
signature 
  Life expectancy < 1 year due to comorbidities 
Number of Patients 
Up to 125 patients, intended to be treated with CTAG Device with ACTIVE 
CONTROL. 
  Total Site enrollment capped at 40 patients 
Number of Sites 
Up to 20 sites in Europe 
Expected Time to Complete 
Enrollment  
12 - 18 months 
Schedule of Events 
Pre-Treatment 
 Physical  
exam  
  Modified Rankin Scale 
  Computed Tomographic Angiography (CTA) of the Chest, Abdomen, 
and Pelvis, with oblique, sagittal, and coronal reconstructions 
Follow-up Visits (Data Collection for One Year) 
Per standard medical practice at each participating site: 
  Modified Rankin Scale  
  Computed Tomographic Angiography (CTA) of the Chest 
  Pathology may necessitate extension of scan range to pelvis 
(e.g., dissection) 
 
 

 
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Coordinating 
Investigator 
Professor Giovanni Torsello 
 
  
 
Germany 
Vendors 
Contract Research Organization 
 
 
  
 
 
Electronic Data Capture System 
 
 
 
 
 
 
 
 

 
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LIST OF ABBREVIATIONS 
AE
 Adverse
 
Event
 
AIS 
Abbreviated Injury Scale 
ASA 
American Society of Anesthesiologists 
CDMS 
Clinical Data Management System 
CE
 Conformité
 
Européenne
 
CEC 
Clinical Events Committee 
cm
 Centimeters
 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CT
 Computed
 
Tomography
 
CTA 
Computed Tomographic Angiography 
CTAG Device 
GORE® TAG
® Conformable Thoracic Endoprosthesis 
CTAG Device with 
ACTIVE CONTROL 
GORE® TAG
® Conformable Thoracic Stent Graft featuring 
ACTIVE CONTROL System 
DTA
 Descending
 
Thoracic
 
Aorta
 
EC
 Ethics
 
Committee
 
EDC 
Electronic Data Capture 
eCRF 
Electronic Case Report Form 
ePTFE
 Expanded
 
Polytetrafluoroethylene
 
FEP
 Fluorinated
 
ethylene
 
propylene
 
Fr
 French
 
(sizing)
 
GCP 
Good Clinical Practice 
GCS 
Glasgow Coma Scale 
ICF 
Informed Consent Form 
IFU
 Instructions
 
for
 
Use
 
ISS 
Injury Severity Score 
NYHA 
New York Heart Association 
mm
 Millimeters
 
MAE 
Major Adverse Event 
mRS 
Modified Rankin Scale 
PI
 Principal
 
Investigator
 
SAE 
Serious Adverse Event 
TEVAR 
Thoracic Endovascular Aortic Repair 
 
 
 

 
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PROTOCOL SUMMARY 
............................................................................................................................................ 
ii 
LIST OF ABBREVIATIONS 
...................................................................................................................................... vi 
1. Introduction ........................................................................................................................................................ 1 
1.1. 
Background 
........................................................................................................................................... 1 
1.2. 
Registry Rationale ............................................................................................................................... 2 
1.3. 
Registry Device Description 
................................................................................................................ 2 
2. Registry Objectives ............................................................................................................................................ 3 
2.1. 
Primary Objective ................................................................................................................................ 3 
3. Registry Design 
.................................................................................................................................................. 4 
3.1. 
Description of Registry Design ...........................................................................................................
  4
 
3.2. 
Registry Endpoints ..............................................................................................................................
 4 
3.2.1.  Primary Endpoints ................................................................................................................ 4 
3.2.2.  Secondary Endpoints ...........................................................................................................
 5 
4. Registry Population 
........................................................................................................................................... 5 
4.1. 
Description of Population 
.................................................................................................................... 5 
4.2. 
Inclusion Criteria ................................................................................................................................. 6 
4.3. 
Exclusion Criteria ................................................................................................................................ 6 
5. Registry Procedures / Evaluations 
................................................................................................................... 6 
5.1. 
Registry Procedures and Evaluation Schema 
................................................................................... 7 
5.2. 
Schedule of Events ..............................................................................................................................
 8 
5.3. 
Informed Consent Process 
.................................................................................................................. 8 
5.4. 
Screening Assessment ........................................................................................................................
  9
 
5.4.1.  Patient Evaluation and Categorization ............................................................................... 9 
 
 
5.5. 
Procedure ............................................................................................................................................. 9 
5.6. 
Additional Interventions ......................................................................................................................
 9 
5.7. 
Follow-Up Visit Windows ...................................................................................................................
  10
 
5.7.1.  Interim Follow-Up Visits Windows .................................................................................... 10 
5.8. 
Patient Withdrawal from the Registry .............................................................................................. 10 
5.9. 
Patient Lost to Follow-Up ..................................................................................................................
 10
 
5.10.  Patient Registry Completion .............................................................................................................
 10
 
5.11.  Device Deficiencies ............................................................................................................................
  1 
 
 
6. Registry Administration .................................................................................................................................. 11 
6.1. 
Monitoring .......................................................................................................................................... 11 
6.1.1.  Site Initiation ........................................................................................................................
  11
 
6.1.2.  Periodic On-Site Monitoring 
 ...............................................
  11
 
6.2. 
Device Accountability ........................................................................................................................
 12
 
6.3. 
Protocol Deviations ............................................................................................................................
  1
2 
6.4. 
Protocol Amendments .......................................................................................................................
 12
 
6.5. 
Access to Source Data / Documents ................................................................................................
  12
 
6.6. 
Registry Records Retention ..............................................................................................................
  12
 
 
 
7. Data Collection and Submission 
.................................................................................................................... 13 
7.1. 
Data Collection Methods ................................................................................................................... 13 

 
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7.2. 
Data Clarification and Correction .....................................................................................................
 13
 
7.3. 
CRF Completion Schedule ................................................................................................................
 13
 
8. Expected Benefits and Potential Risks .......................................................................................................... 
13 
9. Adverse Events and Safety Monitoring 
......................................................................................................... 14 
9.1. 
Adverse Events Classification ..........................................................................................................
  14
 
9.2. 
Event Relationship .............................................................................................................................
 
15 
 
 
9.4. 
Clinical Event Committee ..................................................................................................................
 15
 
10. Statistical Analysis .......................................................................................................................................... 15 
10.1.  Registry Hypotheses ..........................................................................................................................
  15
 
 
 
 
 
10.4.  Data Analysis ..................................................................................................................................... 16 
10.4.1. Timing of Analyses ............................................................................................................. 16 
10.4.2. Analysis Populations ..........................................................................................................
  16
 
10.4.3. Statistical Analysis of Primary Endpoint(s) ..................................................................... 16 
10.4.4. Statistical Analysis of Secondary Endpoint(s) ................................................................ 16 
10.4.5. Additional Analysis .............................................................................................................
  16
 
11. Ethical and Regulatory Considerations 
......................................................................................................... 16 
11.1.  Statement of Compliance ..................................................................................................................
 16 
11.2.  Compliance Responsibilities ............................................................................................................ 17 
11.3.  Informed Consent .............................................................................................................................. 17 
11.4.  Independent Ethical Review ..............................................................................................................
  17
 
11.5.  Conflict of Interest ..............................................................................................................................
 18 
11.6.  Confidentiality 
..................................................................................................................................... 18 
11.7.  Registry Discontinuation or Suspension .........................................................................................
  18
 
12. References 
........................................................................................................................................................ 19 
 
 
 
 
 
 
 
 
 
 

 
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1.  Introduction 
1.1.  Background 
Thoracic endovascular aortic repair (TEVAR) with stent graft implantation is becoming the first 
therapeutic option for treating thoracic aorta pathologies, both in the elective and in the 
emergency setting. 
Several reasons, including reduced perioperative mortality and lower rate of major life-
threatening complications, make this minimally invasive approach the preferred choice over 
the conventional open repair, even for those patients who are unfit for open surgery, due to 
comorbidities and high risk clinical conditions.1-3 
To date, even if no clinical data from randomized trials comparing TEVAR versus open repair 
are available, better procedural and mid-terms outcomes of TEVAR are corroborated by 
several published non-randomized clinical experiences, comparing endovascular repair with a 
concurrent or historical open surgical group, and comprehensive meta-analyses with meta-
regression of available comparative studies. 
Positive clinical outcomes, obtained with the endovascular treatment of the descending aorta, 
induced operators to test endovascular devices in higher risk settings, such as pathologies of 
the aortic arch and ascending aorta, trying to reduce the extremely high incidence of mortality 
and major complications (stroke) associated with open repair of these thoracic aortic 
segments.4-7 
It is recognized that an important factor in TEVAR success, specifically in the aortic arch, is 
dependent on its morphology and the ability of the stent graft to seal off the area of disease or 
injury by appropriate fixation at the proximal and distal landing zones in the normal aorta.
8-12 
In 2010, W. L. Gore & Associates, Inc. (Gore) introduced on the market the new GORE
® TAG
® 
Conformable Thoracic Endoprosthesis (CTAG Device), designed to safely and effectively treat 
multiple thoracic aortic pathologies including aneurysm, type B complicated dissection, and 
traumatic transection, while improving treatment of small diameter, tortuous, and tapered 
aortic anatomy. 
Since then, use of CTAG Device has shown excellent performance in several clinical 
experiences.13, 14 
 
 
 
 
 
 
 
 
 
 
 

 
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1.2.  Registry Rationale 
Post-market observational registries are critical to identify, collect, and analyze medical 
devices outcomes. As the nature of these registries allows for the assessment of medical 
device performance in a real-world setting, data collected are useful for many purposes, such 
as short- and long-term surveillance of marketed products, fulfillment of post-market 
observational registry commitments for regulatory bodies, bridging the gap between device 
performance in clinical trials, and their use in routine practice over time. 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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For detailed description and use of the device, please refer to the Instructions for Use (IFU). 
 
2.  Registry Objectives 
2.1.  Primary Objective 
The primary objective of the registry is to collect real-world clinical and device-specific 
outcomes of the CTAG Device with ACTIVE CONTROL in the treatment of aortic disease as 
part of routine clinical practice.  
 
 

 
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3.  Registry Design 
3.1.  Description of Registry Design 
This registry is an observational, prospective, single-arm, post-market registry. A maximum of 
20 clinical investigative sites (referred to as “sites” in the remainder of this document) in 
Europe will participate in this registry. Up to 125 patients, in total, will be enrolled in the 
registry. The anticipated accrual rate is approximately two patients per month per site for a 
total accrual period of approximately 12 – 18 months. The total estimated registry duration is 
30 months. A maximum enrollment cap of forty (40) patients at any one site will be instituted to 
ensure that the registry is composed of multi-center data.  
Patients may be enrolled into the registry provided all inclusion and no exclusion criteria are 
met as specified in Sections 4.2 and 4.3. All consecutive patients meeting protocol selection 
criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL 
will be included in the registry. Patients will be evaluated through hospital discharge and at 
their anticipated short term (approximately 30 days after the procedure) and first annual 
(approximately 12 months) follow-up evaluations. Additional follow-up visits in this 12 month 
period will be done according to standard of care at each site and should be documented 
accordingly. The timing of the follow-up evaluations are consistent with standard medical 
surveillance for a post thoracic stent-graft patient. Due to its observational nature, the registry 
will not require the use of a registry device in a specific pathology, the number of patients in a 
particular pathology, or the scope of the registry device’s use once inclusion / exclusion criteria 
have been verified. 
3.2.  Registry Endpoints 
3.2.1.  Primary Endpoints 
1.  Procedural technical success,  
 
 
 
 
 
 
 
 
 
 
 
 
2.  Treatment Success at the 30-day visit (see follow-up visit window schedule in 
Table 2) as defined as technical success and freedom from: 
 
 
 
 
 
 
 
 
 
 

 
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3.2.2.  Secondary Endpoints 
1.  Freedom from the following Major Adverse Events (MAEs) through 12 months, 
described individually at the 30-day and 12-month visits (see follow-up visit 
window schedule in Table 2).   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
2.  Treatment Success at 12 months defined as technical success and freedom from: 
 
 
 
 
 
 
 
 
3.  Freedom from the incidence of SAEs, other than MAEs, throughout the registry 
duration 
4.  Measures of Pathology-Specific Remodeling: 
 
  
 
 
 
4.  Registry Population 
4.1.  Description of Population 
All consecutive patients presenting with an indication for endovascular repair of the thoracic 
aorta, in accordance with applicable guidelines for endovascular interventions, are eligible for 
screening for participation in the registry. Enrolled patients will be characterized by common 
risk classification scales, anatomical presentation, and applicable, pathology-specific 
descriptors as described in Sections 13.1 and 13.2. 
Only patients who meet all of the inclusion criteria and none of the exclusion criteria may be 
enrolled. 
 
 

 
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4.2.  Inclusion Criteria 
1. Age 
≥ 18 years 
2.  Signed informed consent form 
3.  Willingness, in the opinion of the investigator, to adhere to standard of care follow-up 
requirements 
4.  Surgical indication for TEVAR based on investigator’s best medical judgment 
5.  Intent to treat with CTAG Device with ACTIVE CONTROL. 
4.3.  Exclusion Criteria 
1.  Paraplegia or paraparesis at initial presentation 
2.  Participation in concurrent research study or registry which may confound registry results, 
unless approved by Sponsor 
3.  Prior implantation of a thoracic stent graft 
4.  Pregnant or breast-feeding female at time of informed consent signature 
5.  Life expectancy < 1 year due to comorbidities 
5.  Registry Procedures / Evaluations 
Due to its observational nature, the registry will not require the use of any procedure and / or test 
and / or medical device different from those required by routine clinical practice for treating the 
investigated pathology. 
The sponsor will not impose requirements that limit health care professionals from exercising 
their best medical judgment for treatment. Therefore, patient selection, diagnostic imaging, and 
treatment interventions will be determined by physicians based on clinical practice standards. 
 
 

 
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5.1.  Registry Procedures and Evaluation Schema 
 
Figure 2: Registry Activity Flowchart 
 
 
 
 

 
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5.2.  Schedule of Events 
Anticipated assessments for data collection are described in Table 1. Visit intervals for 
organization and reporting purposes are provided in Section 5.7. 
 
Table 1: Schedule of Events  
 
Screening 
Procedure Discharge 
30-day 
Follow-
up* 
Additional 
Routine 
Follow-
up* 
12 Month 
Follow-
up* 
Informed Consent  
X 
 
 
 
 
 
Demographics and 
Medical History 
X
 
 
 
 
  
 
ASA and NYHA  
X 
 
 
 
 
 
Physical Exam  
X 
 
 
 
 
 
Modified Rankin 
Scale, if able 
X
 
 
 
 X
 
X
 
X
 
Post-deployment 
Angiogram 
 X
 
 
 
 
 
Assessment of 
Adverse Events 
 
 
X
 
X
 
X
 
X
 
CT Angiogram, per 
standard of care** 
X
 
 X
 
X
 
X
 
X
 
*Per clinical practice follow-up standards 
** A CTA at either discharge or at 30 days is expected, as well as at least one follow-up CTA in the follow-up time after 30 days 
5.3.  Informed Consent Process  
As this protocol is not requiring procedures different from those routinely performed to treat 
thoracic pathologies with a thoracic endovascular stent graft, patients will provide written 
informed consent to authorize Gore to collect, process, and disseminate their demographic 
and clinical data, according to applicable data protection laws and regulations. Any documents 
provided to Gore will be processed by the site to remove any information that could identify the 
patient.  
Patients are asked to sign an Ethics Committee (EC)-approved informed consent form (ICF) 
prior to the device implant. The EC-approved ICF will be signed and dated by the patient as 
well as the person who administered the ICF. In the event it is not possible for the patient to 
provide consent prior to the implant, e.g., in an emergency situation, consent may be obtained 
afterward, but it should occur prior to discharge. 
Each patient will be informed of his / her right to withdraw from the registry at any time, without 
compromising his / her treatment.  
The original, signed ICF will be retained in the patient records along with a brief note detailing 
the consenting process. A copy of the ICF will be given to the patient for their records. 
 
 

 
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5.4.  Screening Assessment 
5.4.1.  Patient Evaluation and Categorization 
Patients will be evaluated for the registry based upon current physical status, 
pertinent medical history, risk categorization scales, and pathology-specific 
descriptors. Computed Tomographic Angiography (CTA) will be performed to assess 
anatomical candidacy for the CTAG Device with ACTIVE CONTROL to include 
diameter / length measurements, characterization of aortic anatomy, and perform 
device case planning. The standardized scales and descriptions used to define and 
describe the registry population are described in Appendix B and Appendix C of the 
protocol.  
 
 
 
 
 
  
 
5.5.  Procedure 
The device implant procedure should be performed according to each participating site’s 
standard practice. No specific procedures are required by the protocol. 
A patient is considered enrolled in the registry once the CTAG Device with ACTIVE CONTROL 
delivery catheter is introduced into the vasculature and the EC-approved ICF is signed by the 
patient. 
  
Patients who do not undergo successful deployment of the CTAG Device with ACTIVE 
CONTROL will be followed for safety events through their 30-day follow-up visit, then 
discontinued. Unsuccessful deployment is defined as introduction of the CTAG Device with 
ACTIVE CONTROL delivery catheter into the vasculature but not deployed within a patient. 
The introduction of an introducer sheath, by itself, would not be considered an unsuccessful 
deployment. Additional adjunctive treatments to the TEVAR implant procedure may be 
performed at the discretion of the investigator. Additional treatments performed at the time of 
the initial procedure will be recorded in the “Adjunctive Treatment” section of the Treatment 
Electronic Case Report Form (eCRF). 
5.6.  Additional Interventions 
Additional interventions may be performed at the discretion of the investigator. An additional 
planned intervention may occur during the initial procedure or as part of a staged procedure. A 
staged procedure is defined as the intentional completion of the endovascular repair in 
multiple temporarily separate procedures. An additional planned or unplanned intervention 
occurring during the initial procedure should be captured in the Adjunctive Treatment Section 
of the Treatment eCRF. An additional planned intervention occurring as part of a staged 
procedure should be captured on the Additional Treatment eCRF. 
An additional unplanned intervention (defined as unanticipated, additional surgical or 
endovascular intervention) occurring after the initial procedure meeting either of the following 
definitions will be considered a reintervention: 

 
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1.  Associated with an Adverse Event (AE). These reintervention procedures will be captured 
as AE treatments on the Adverse Event eCRF. 
2.  Any cardiothoracic surgery or percutaneous intervention catheter procedure that repairs, 
otherwise alters or adjusts, or replaces a previously implanted stent graft used in the 
primary procedure. 
Patients undergoing a reintervention should be kept in the registry and followed-up according 
to the participating site’s standard practice. 
5.7.  Follow-Up Visit Windows 
Patients’ follow-up should be performed according to the site’s standard of care, with a 
minimum of two follow-up visits, conducted at approximately 30 days and again at 
approximately 12 months following the initial procedure. For registry reporting, the follow-up 
visit windows are defined according to Table 2.  
Table 2: Follow-Up Visit Windows  
Follow-up Visit 
Visit Window (days) 
30 Days 
15-59 
Additional Routine Follow Up Visits  
60-274 
12 Months 
275-455 
 
5.7.1.  Interim Follow-Up Visits Windows 
Registry investigators may elect to employ a more intensive follow-up regimen that is 
part of their standard practice or tailored to the medical needs of his / her patient. 
Device evaluations conducted outside of the protocol-described follow-up visit 
windows are requested to be entered into the Electronic Data Capture (EDC) system. 
These interim evaluations may provide additional context to identified AEs. 
5.8.  Patient Withdrawal from the Registry 
A patient may withdraw from the registry at any time and should notify the investigator in this 
event. The investigator, in this case, should complete the appropriate Discontinuation eCRF.  
5.9.  Patient Lost to Follow-Up 
The investigator should encourage patients to complete all routine follow-up visits and notify 
them of significant changes in their health, especially when potentially device-related (e.g., 
reinterventions) events occur. 
Due to the brief follow-up period for the registry, an enrolled patient cannot be considered lost 
to follow-up by the investigator until the follow-up visit window of 12 months has elapsed. 
Investigators are expected to collect device performance data during this time according to 
good clinical practice. This includes utilizing varied contact methods (i.e., phone, mail, and 
certified mail) to secure follow-up data or contacting family for updated contact information or 
to check on the vital status of the patient. 
5.10. Patient Registry Completion 
A patient has completed the registry when he / she completes the 12 month follow-up visit, 
according to the visit window reported in Table 2. 

 
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Any patient that does not complete these requirements due to voluntary withdrawal, physician 
withdrawal, death, or any other reason will be considered a withdrawal. Since patients are 
being treated per standard of care, they will not be provided with any medical care by Gore.  
5.11. Device Deficiencies 
Device deficiencies are defined by ISO 14155 as inadequacy of a medical device with respect 
to its identity, quality, durability, reliability, safety, or performance. Device deficiencies include 
malfunctions, use errors, or inadequate labelling.  
As CTAG Devices with ACTIVE CONTROL are commercialized medical products, device 
deficiency reporting will follow established, country-specific complaint reporting processes and 
product surveillance mechanisms in addition to entry into the EDC system on the appropriate 
eCRFs. 
 
 
 
 
 
6.  Registry Administration 
6.1.  Monitoring 
Site monitoring for this registry will be provided by  
 with oversight provided by Gore. 
The monitors are qualified by training and experience to oversee the progress of the registry at 
the site and will verify that investigators and their staff understand and adhere to both the 
applicable regulatory requirements and the registry protocol. In addition, they may assist in 
resolution of any problems that may arise during the registry. 
6.1.1.  Site Initiation 
Site initiation will be performed to verify that each investigator and his / her staff 
understands the protocol, applicable regulations, human patient protection 
requirements, and the investigator’s obligations. This visit will confirm that required 
documentation with the appropriate approval is in place prior to patient enrollment. 
6.1.2.  Periodic On-Site Monitoring 
  
Periodic, on-site monitoring will occur as necessary to verify continuing adequacy of 
facilities and adherence to the registry protocol, GCPs, and applicable regulations 
and laws that pertain to the conduct of the registry. These activities will also review 
the CRFs and source documentation, the timely submission of accurate records to 
Gore, and the maintenance of proper records. A report will be written following each 
site visit and a follow-up letter will be provided to the site with a summary of findings. 
Each site will also be visited at close-out to confirm that all documentation is 
complete. 

 
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Informed consent 
documentation for all patients will be reviewed at an on-site visit to verify that all 
patients agreed to registry participation. Monitoring procedures and requirements will 
be documented in a clinical monitoring plan developed and maintained by Gore.  
6.2.  Device Accountability 
Participating sites will adhere to their current commercial contractual agreement with Gore or 
designee for device shipping, storage, use, and return. Reference and lot number of implanted 
devices or opened, unused devices will be collected on eCRFs. 
6.3.  Protocol Deviations 
A protocol deviation is defined as any change, divergence, or departure from the registry 
design or procedures of a research protocol. The investigator is responsible for promptly 
recording and reporting protocol deviations to Gore and the reviewing EC per their policy.  
For the purpose of this registry, as implant procedures and follow-up visits will be performed 
according to participating sites’ standard practice, protocol deviations would only affect the 
informed consent signature process or patient enrollment process.  
Gore will determine the effect of the protocol deviation on the scientific soundness of the 
registry as well as patient safety and determine if additional reports or actions are required. 
Additional action may include site retraining, and / or site termination. 
6.4.  Protocol Amendments 
Sponsor will submit to ECs all amendments for approval in a timely manner and will confirm 
proper training of investigator and site staff on all protocol amendments, if needed. 
6.5.  Access to Source Data / Documents 
Source data are defined as all information necessary for the reconstruction and evaluation of 
the registry. 
The investigator will keep all registry records and source data available for inspection by Gore, 
Gore’s monitors, EC, and regulatory authorities. 
6.6.  Registry Records Retention 
The investigator will maintain complete, accurate, and current registry records as required by 
applicable regulatory requirements. Records will be maintained during the registry and for a 
minimum of five years after registry is completed or terminated. In any event, registry records 
will not be disposed of, nor custody of the records transferred, without prior written sponsor 
approval. 
Investigator records will include, but not be limited to:  
  All correspondence with another investigator, an EC, Gore, a monitor, or regulatory 
authority, including required reports. 
  Records of each patient’s case history and exposure to the device. Case histories include 
the CRFs and supporting data including, for example, signed and dated consent forms and 
medical records, including progress notes of the physician, the individual’s hospital chart(s), 
and the nurses’ notes. Such records shall include: 

 
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o  The protocol, any amendments, annual registry report, and documentation of any 
deviations from the protocol, including the dates and the reasons for such 
deviations. 
o  Any other records that regulatory authorities require to be maintained by regulation 
or by specific requirement for a category of investigations or a particular 
investigation. 
o  Any other records as required by the regulatory authority, the EC, or Gore. 
  
 
 
 
 
 
7.  Data Collection and Submission 
The Clinical Data Management System (CDMS) for this registry will be provided by: 
 
 
 
7.1.  Data Collection Methods  
This registry will report clinical data using
CDMS system. The CDMS will be the 
database of record for the protocol and may be subject to regulatory inspections. All users will 
be trained to use the CDMS and will comply with registry-specific guidelines / instructions as 
well as applicable regulatory requirements. 
Patient data will be collected using protocol-specific eCRFs. Site staff will enter data directly 
into the eCRF for transmission to the sponsor. The sites will be notified of any significant 
amendments to the eCRFs. 
7.2.  Data Clarification and Correction 
Once entered, data will be evaluated to confirm that they are complete, consistent, and 
logically sound. If changes to the data in the CDMS are required, all changes, reasons for 
changes, and persons making the changes will be captured in the CDMS
's audit trail. 
7.3.  CRF Completion Schedule 
Entry of patient data into the EDC system cannot occur prior to the collection of the patient’s 
informed consent to participate in the registry. EDC entry should be contemporaneous with a 
goal of complete study visit entry within 14 days of a clinical evaluation.  
8.  Expected Benefits and Potential Risks  
Participation in this observational registry is not expected to provide any direct benefits to 
participating patients, other than those related to the treatment of the thoracic aortic pathology. 
However, the data collected during the registry will foster a better understanding of the performance 
of the registry devices in real world, daily application. 

 
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Moreover, as the registry will not require the use of any procedure and / or test and / or device 
different from those required by routine clinical practice for the investigated condition, enrolled 
patients will not be exposed to additional risks as compared to routine clinical practice. 
9.  Adverse Events and Safety Monitoring 
Adverse Events (AEs) are defined as any untoward medical occurrences in a patient whether 
device-related or not. For the purpose of this registry, all adverse events, regardless of seriousness 
or relationship, will be reported in accordance with applicable regulations, collected into the 
appropriate eCRF form, and documented in the patient’s permanent medical record. The investigator 
at each site is ultimately responsible for reporting SAEs and device events to the sponsor. 
The following information will be collected for each reportable event: 
  Adverse Event Description 
  Adverse Event Onset Date 
 Relationship  
 Classification  
 Treatment  
 Outcome  
 Resolution  
Date  
All reportable events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). 
Event guidelines: 
  Reporting begins once the patient is enrolled in the registry. All reportable events will be 
collected from enrollment through registry completion / discontinuation. 
  Provide a diagnosis if possible. If unable to provide a diagnosis, report the symptoms as 
separate events. Reportable events will include a description that is free of abbreviations or 
narratives. 
  Reportable events with an outcome status of “Ongoing” should be assessed at each follow-
up evaluation to determine if the event has resolved. SAEs ongoing at registry completion / 
discontinuation should be left as “Ongoing” on the SAE case report form. 
9.1.  Adverse Events Classification 
Each AE will be assessed by the investigator to determine if it is serious or non-serious, 
according to ISO 14155:2011. An SAE is defined as satisfying any of the following:  
  led to death 
  led to serious deterioration in the health of the patient that either resulted in 
o  a life threatening illness or injury, or 
o  a permanent impairment of a body structure or body function, or 
o  inpatient or prolonged hospitalization, or 
o  medical or surgical intervention to prevent life threatening illness or injury or 
permanent impairment to a body structure or a body function 
  led to fetal distress, fetal death or a congenital abnormality or birth defect 
A planned hospitalization for a pre-existing condition, without serious deterioration in health, is 
not considered an SAE. 

 
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Any AE that does not meet the criteria for SAE is termed a non-serious adverse event. 
9.2.  Event Relationship 
Each reported event will be assessed by the investigator for its primary suspected relationship, 
according to the following definitions: 
 Registry Device-related  
The functioning or characteristics of the registry device caused or contributed to the event. 
 Registry Procedure-related  
The procedure to implant the registry device (and not the registry device itself) caused or 
significantly contributed to the event. 
 Not-related  
An event which cannot be attributed to the registry device or procedure. 
 Unknown relationship  
The relationship of the event to the registry device, procedure, or disease cannot be 
determined. 
Event relationships initially reported as “Unknown” will need to be re-evaluated, when feasible, 
to foster a more definitive causality for event reporting and device attribution. 
 
 
 
 
 
 
 
  
9.4.  Clinical Event Committee 
A Clinical Events Committee (CEC), 
 who are independent of Gore 
and with relevant clinical expertise, will ensure consistent and accurate reporting for select 
AEs and all deaths. Candidate events for CEC adjudication will be identified using a 
systematic process for events that may contribute to a registry secondary endpoint, associated 
with death or individually asked for adjudication by Gore. 
The CEC will review and confirm identified events for causality and severity with an 
assessment on potential applicability to registry secondary endpoints.  
 
 
10.  Statistical Analysis 
 
 
 
 
 

 
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10.4.  Data Analysis 
10.4.1. Timing of Analyses 
The final analysis will be performed when all patients have completed their 12 month 
follow-up visit or have been withdrawn from the registry. Analyses will be performed 
as needed for annual reports. 
 
 
10.4.2.  Analysis Populations 
All enrolled patients meeting the inclusion / exclusion criteria and treated with the 
CTAG Device with ACTIVE CONTROL will be included in the primary and secondary 
endpoint analyses. 
10.4.3.  Statistical Analysis of Primary Endpoint(s) 
Tables of the primary endpoints—procedural technical success and treatment 
success at 30 days will be reported. Data will be presented descriptively with 
confidence intervals. 
10.4.4.  Statistical Analysis of Secondary Endpoint(s) 
Tables of the secondary endpoints—incidence of MAEs, incidence of SAEs, and 
pathology-specific measures of remodeling will be reported. Data will be presented 
descriptively with confidence intervals, where appropriate. 
 
 
 
 
11.  Ethical and Regulatory Considerations 
11.1.  Statement of Compliance 
The registry will be conducted in compliance with this protocol, ISO 14155:2011, and local 
applicable regulatory requirements. 
The following are applicable to this registry: 
Medical Device Directive 
(93/42/EEC) 
Article 15 Annex X 
Council Directive 93/42/EEC of 14 June 
1992 
Amendment to the MDD 
(2007/47/EC) 
Article 15 Annex X 
Directive 2007/47/EC of the European 
Parliament and of the Council of 5 
September 2007 

 
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ISO 14155:2011 (E) 
Clinical investigation of medical devices 
for human subjects – Good clinical 
practice 
 
11.2.  Compliance Responsibilities 
Gore will conduct the registry in accordance with all applicable regulations and laws. Gore will 
be responsible for documenting that investigators have the necessary skills, training, and 
information to properly contribute to the registry. Investigators are physicians who have stent-
graft implant privileges and can coordinate medical follow-up following the procedure. Other 
delegated staff such as research coordinators, physician assistants, or nurse practitioners 
cannot serve in the role of investigator. Gore will confirm proper monitoring of the registry and 
verify that the site has obtained EC approval prior to enrollment. Gore will provide information 
to the investigators and the reviewing ECs, if needed, concerning the progress of the registry. 
The investigator will conduct the registry in accordance with all applicable regulations and 
laws, any relevant agreements, the protocol, and all approval conditions of the reviewing ECs. 
The investigator and Gore will verify EC approval is obtained prior to enrollment, maintained 
throughout the course of the registry, and that all EC reporting requirements are met. The 
investigator is responsible for protecting the rights, safety, and welfare of patients under the 
investigator’s care. The investigator is also responsible for ensuring that informed consent is 
properly obtained. 
The registry shall be conducted in accordance with the ethical principles that have their origin 
in the Declaration of Helsinki. 
11.3.  
Informed Consent 
The investigator shall verify that all potential patients for this registry are provided with an EC-
approved ICF describing the registry with sufficient information to make an informed decision 
about their participation. 
The formal consent of a patient, using the EC-approved consent form, should be obtained by 
the investigator before that patient undergoes the initial procedure or, in case of emergency, 
prior to hospital discharge. The consent form will be signed and personally dated by the 
patient and the person who conducted the informed consent discussion. The original signed 
ICF will be retained in the patient records. A copy of the informed consent document will be 
given to the patient for his or her records. Any significant, new information which emerges 
while the registry is in progress that may influence a patient’s willingness to continue to take 
part in the registry will be provided to the patient. 
The investigator shall verify that documentation of the acquisition of informed consent is 
recorded in each patient’s records in accordance with applicable regulations. 
11.4.  
Independent Ethical Review 
The investigator shall not enroll any patients prior to obtaining approval for the registry from his 
or her site’s EC. 
The sponsor and / or designee will be responsible for submission of the investigator’s 
brochure, protocol, draft ICF, eCRF (data requirements), and any other document required by 
each local EC, for EC’s written approval. 
 
 

 
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11.5.  Conflict of Interest 
All investigators will follow applicable laws and regulations as well as the conflict of interest 
policies of their site and the reviewing EC. 
11.6.  Confidentiality 
All patient records will be kept confidential to the extent provided by applicable laws and 
regulations. The registry monitors and other authorized representatives of Gore may inspect 
all documents and records required to be maintained by the investigator, including but not 
limited to, medical records. 
Such records may also be reviewed by the site’s EC and other regulatory bodies in Europe 
and in the United States, as detailed in the ICF. 
11.7.  Registry Discontinuation or Suspension 
Gore may suspend or prematurely terminate the registry at either an individual site or at all 
participating sites for significant and documented reasons. Gore could consider terminating or 
suspending the participation of a particular clinical site or a specific investigator if Gore 
oversight identifies serious and / or repeated deviations from the protocol. 
If, for any reason, Gore suspends or prematurely terminates the registry or an investigator at 
an individual clinical site, Gore will notify the applicable EC. 
 
 

 
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12.  References 
1.  Xenos ES, Abedi NN, Davenport DL, Minion DJ, Hamdallah O, Sorial EE, et al. Meta-analysis of 
endovascular vs open repair for traumatic descending thoracic aortic rupture. J Vasc Surg. 
2008;48(5):1343-51. 
2.  M T. Coming Soon: TEVAR in the Ascending Aorta? Endovascular Today. 2011:61-3. 
3.  Scali ST, Goodney PP, Walsh DB, Travis LL, Nolan BW, Goodman DC, et al. National trends and 
regional variation of open and endovascular repair of thoracic and thoracoabdominal aneurysms in 
contemporary practice. J Vasc Surg. 2011;53(6):1499-505. 
4.  Jonker FH, Trimarchi S, Verhagen HJ, Moll FL, Sumpio BE, Muhs BE. Meta-analysis of open 
versus endovascular repair for ruptured descending thoracic aortic aneurysm. J Vasc Surg. 
2010;51(4):1026-32, 32.e1-32.e2. 
5.  Cheng D, Martin J, Shennib H, Dunning J, Muneretto C, Schueler S, et al. Endovascular aortic 
repair versus open surgical repair for descending thoracic aortic disease a systematic review and 
meta-analysis of comparative studies. J Am Coll Cardiol. 2010;55(10):986-1001. 
6.  Bavaria JE, Appoo JJ, Makaroun MS, Verter J, Yu ZF, Mitchell RS. Endovascular stent grafting 
versus open surgical repair of descending thoracic aortic aneurysms in low-risk patients: a 
multicenter comparative trial. J Thorac Cardiovasc Surg. 2007;133(2):369-77. 
7.  Walsh SR, Tang TY, Sadat U, Naik J, Gaunt ME, Boyle JR, et al. Endovascular stenting versus 
open surgery for thoracic aortic disease: systematic review and meta-analysis of perioperative 
results. J Vasc Surg. 2008;47(5):1094-8. 
8.  Alberta HB, Takayama T, Smits TC, Wendorff BB, Cambria RP, Farber MA, et al. Aortic Arch 
Morphology and Aortic Length in Patients with Dissection, Traumatic, and Aneurysmal Disease. 
Eur J Vasc Endovasc Surg. 2015;50(6):754-60. 
9.  De Rango P, Ferrer C, Coscarella C, Musumeci F, Verzini F, Pogany G, et al. Contemporary 
comparison of aortic arch repair by endovascular and open surgical reconstructions. J Vasc Surg. 
2015;61(2):339-46. 
10.  Canaud L, Marty-Ane C, Ziza V, Branchereau P, Alric P. Minimum 10-year follow-up of 
endovascular repair for acute traumatic transection of the thoracic aorta. J Thorac Cardiovasc 
Surg. 2015;149(3):825-9. 
11.  Faure EM, Canaud L, Agostini C, Shaub R, Boge G, Marty-ane C, et al. Reintervention after 
thoracic endovascular aortic repair of complicated aortic dissection. J Vasc Surg. 2014;59(2):327-
33. 
12.  Hiraoka A, Chikazawa G, Tamura K, Totsugawa T, Sakaguchi T, Yoshitaka H. Clinical outcomes of 
different approaches to aortic arch disease. J Vasc Surg. 2015;61(1):88-95. 
13.  Jordan WD, Jr., Rovin J, Moainie S, Bavaria J, Cambria R, Fillinger M, et al. Results of a 
prospective multicenter trial of CTAG thoracic endograft. J Vasc Surg. 2015;61(3):589-95. 
14.  Makaroun MS, Dillavou ED, Wheatley GH, Cambria RP. Five-year results of endovascular 
treatment with the Gore TAG device compared with open repair of thoracic aortic aneurysms. J 
Vasc Surg. 2008;47(5):912-8. 
15.  Waterford SD, Chou D, Bombien R, Uzun I, Shah A, Khoynezhad A. Left Subclavian Arterial 
Coverage and Stroke During Thoracic Aortic Endografting: A Systematic Review. Ann Thorac Surg. 
2016;101(1):381-9. 
16.  DeSart K, Scali ST, Feezor RJ, Hong M, Hess PJ, Jr., Beaver TM, et al. Fate of patients with spinal 
cord ischemia complicating thoracic endovascular aortic repair. J Vasc Surg. 2013;58(3):635-42 e2. 

 
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17.  Acher C, Acher CW, Marks E, Wynn M. Intraoperative neuroprotective interventions prevent spinal 
cord ischemia and injury in thoracic endovascular aortic repair. J Vasc Surg. 2016. 
18.  Casserly IP, Sachar R, Yadav JS. Manual of Peripheral Vascular Intervention: Lippincott Williams & 
Wilkins; 2005. 
19.  Fillinger MF, Greenberg RK, McKinsey JF, Chaikof EL, Society for Vascular Surgery Ad Hoc 
Committee on TRS. Reporting standards for thoracic endovascular aortic repair (TEVAR). J Vasc 
Surg. 2010;52(4):1022-33, 33 e15. 
 
 

 
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