Evaluation on the Treatment of Diseases of the Thoracic Aorta With the Thoracic Endoprosthesis GORE® TAG®
Conditions: Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection, Aortic Diseases, Aorta Thoracic; Traumatic Rupture, Penetrating Ulcer
Sponsor: W.L.Gore & Associates

 
 
Nothing herein is to be disclosed in any way without the prior 
express written permission of W. L. Gore & Associates, Inc. 
 
 
 
 
Observational Study of the GORE® TAG® Thoracic Endoprosthesis in the treatment of 
diseases of the thoracic aorta 
 
 
 
 
 
 
Protocol number: FPR 12-03 
 
Protocol date: 21-SEP-2015 
 
NCT number: NCT02266342 
 
 
 
 
 
 
 
 
W. L. Gore & Associates, Inc. 
Medical Products Division 

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SUMMARY 
 
Title 
Observational Study of the GORE® TAG® Thoracic Endoprosthesis in the treatment of 
diseases of the thoracic aorta 
 
 
Basis 
The endoprosthetic treatment of diseases of the thoracic aorta, including aneurysms, 
dissections, penetrating ulcers and isthmus rupture, seems to provide a plausible benefit 
compared to surgery in terms of operative mortality and severe morbidity. However, 
there is inadequate data on the long-term outcome of such endoprostheses. This is why 
the French National Health Authority requires a 5-year follow-up as part of the 
reimbursement renewal process for these endoprostheses. This long-term observational 
study was established for this reason.  
 
Methodology of the observational study 
A French-language, prospective, multicenter, non-randomized, single-arm, open-label 
observational study. 
 
Study device 
The devices included in the observational study are the GORE® TAG® and 
Conformable GORE® TAG® Thoracic Endoprostheses, including any newer models 
 
 
Study population 
Enrollment criteria:  
• 
Any patient with a GORE® TAG® or Conformable GORE® TAG® Thoracic 
Endoprosthesis implant (successful or otherwise) for the treatment of a 
descending thoracic aortic disease.  
• 
Patients who have previously consented to the collection and use of their 
personal medical information. 
• 
18 years or older at the time of treatment.   
 
Exclusion criteria: 
• 
Patients who have already received treatment with a thoracic endoprosthesis 
other than the GORE® TAG® and the Conformable GORE® TAG® Thoracic 
Endoprostheses and for whom a “revision” or repeat intervention is required.  
• 
Patients whose clinical follow-up is not possible (e.g., patients who cannot return 
for control visits because they live abroad). 
 
All eligible patients and those requiring treatment with the study endoprosthesis will be 
candidates for enrollment in this observational study. A patient shall be considered as 

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Secondary endpoints 
The secondary endpoints for assessing the usefulness of the technique at different 
follow-up visits (after surgery or in the month following the surgery, at 1 year, then each 
year thereafter) shall be: 
• 
The exclusion rate of the aneurysm, the penetrating aortic ulcer, the false lumen 
or rupture site, with no endoleak, regardless of type 
• 
The rate of neurological complications 
• 
The rate of cardiac, renal and pulmonary complications 
• 
The rate of device-related complications 
• 
The rate of surgical conversion 
• 
The rate of secondary procedures 
• 
The rate of mortality related to the disease 
A report will be submitted each year to the French National Health Authority. 
 
Duration of the observational study 
• 
Enrollment period for the 160 patients: 24 months 
• 
Follow-up period for each patient: 5 years 
• 
Total duration of the study: 7 years (84 months) 
 
Follow-up of the observational study 
The schedule and procedures for monitoring the patients included in this study shall  
conform with the recommendations of the French National Health Authority2, namely 
annual monitoring by CT scan or MRI + X-ray for 5 years.  
 
Monitoring schedule and procedures recommended by the French National Health 
Authority: 
 
Post-operative 
follow-up 
(D1 to D30) 
Follow-
up at  
1 year 
Follow-
up at  
2 years 
Follow-
up at  
3 years 
Follow-
up at  
4 years 
Follow-
up at 
5 years 
Clinical evaluation 
X 
X 
X 
X 
X 
X 
CT scan or 
MRI + X-ray 
X 
X 
X 
X 
X 
X 
 
This is an observational study, therefore there is no requirement for any specific 
examination or procedure outside the scope of practice of each center. This schedule 
and the monitoring procedures may be alleviated based on future recommendations.  
 
Regulatory aspects 
Before any patient is enrolled, this study will be subject to various required reviews and 
authorizations in compliance with existing regulations.  
 
Patient information 
This is an observational study; the investigator shall inform the patient about the nature 
and objectives of the data collection and answer all of the patient's questions. An 
informational note has therefore been prepared for the patients, informing them of their 

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1 GENERAL INFORMATION 
 
1.1 Introduction 
As per the current state of evidence, the endoprosthetic treatment of diseases of the 
thoracic aorta, including aneurysms, dissections and isthmus rupture, seems to provide 
a plausible benefit in terms of operative mortality and severe morbidity, subject to a 
rigorous mid-term evaluation [average rate of paraplegia 2.1% (range: 0 to 7%) with 
endoprostheses versus 5% (range: 3 to 15%) with surgery]. 
Conventional treatments are surgical treatment on the one hand and/or medical 
treatment, on the other hand. Surgical treatment requires major surgery with initiation of 
a cardiopulmonary bypass and can only be provided to patients who can tolerate the 
surgical risk. Medical treatment mainly consists of managing the hypertension.  
The therapeutic strategy varies depending on the disease concerned:  
 
Aneurysm of the thoracic aorta: 
The benchmark treatment is open surgery with implantation of the prosthesis after 
initiation of a cardiopulmonary bypass.  
The rates of surgical morbidity and mortality are different in the elective and emergency 
treatments, specifically in terms of the risk of spinal cord ischemia, resulting in 
paraparesis or paraplegia. The operative mortality rates of descending thoracic aorta 
aneurysms in elective surgery vary between 6% and 15%, and are significantly higher in 
emergency surgery. The risk of paraparesis or paraplegia is estimated between 3% and 
15%.3 
 
The major complications are as follows3 (about 5% each): 
• 
Bleeding requiring secondary surgical revision 
• 
Respiratory failure with prolonged respiratory aid 
• 
Acute renal failure 
• 
Central neurological events (stroke and coma) 
• 
Peripheral neuropathies (sensorimotor deficits, paraparesis, paraplegia) 
• 
Infections 
 
The contraindications to surgery are patients over 80 years old, chronic respiratory 
failure, renal failure, coronary artery diseases and generalized diseases (neoplasia, 
etc.).3 
 
 
Thoracic aortic dissections: 
The benchmark treatment differs, depending on whether it is a type A dissection 
(ascending aorta origin) or a type B dissection (descending aorta origin). Type A 
dissections require emergency surgical treatment. For uncomplicated type B dissections, 
antihypertensive medical treatment is the benchmark treatment. In the event of 
complications, surgery is indicated. Contraindications to surgical treatment are mainly 
related to older patient age and cardiorespiratory issues. Acute hemiplegia or mesenteric 
infarction of more than 6 hours are also contra-indications for surgery2. In the acute 
phase, mortality rates for surgical treatment range between 20 and 35% and medullary 
complications between 10 and 20%. 

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1.2.2 Terms of use and prescription recommended by CNEDiMTS 
The implantation of the GORE® TAG® and/or Conformable GORE® TAG® Thoracic 
Endoprostheses must be conducted in accordance with the recommendations2 made by 
the French National Health Authority (HAS) specifically: 
• 
The implantation must be performed in centers with expertise in both 
endovascular and surgical treatments, and with adequate technical equipment 
• 
The implementation of a multidisciplinary study, in particular on the risk of 
surgical conversion and the possible use of a cardiopulmonary bypass (CPB) 
• 
Verification of the presence of a proximal neck at least 2 cm long, allowing for the 
insertion of the endoprosthesis 
• 
The need to inform patients of the benefits and disadvantages of the available 
repair techniques, such as open-heart surgery and endo-aortic prosthesis (EAP). 
• 
Annual monitoring by CT scan or MRI + X-ray 
The follow-up of patients in a prospective observational study is requested by 
CNEDiMTS. The data from this study on the implantation and monitoring of the GORE® 
TAG® and the Conformable GORE® TAG® Thoracic Endoprostheses will be required 
on renewal of registration.  
 
 
2 PLAN OF THE OBSERVATIONAL STUDY 
 
2.1 Goals of this study 
The purpose of this study is to evaluate the usefulness of the technique in terms of the 
efficacy and safety of use of the GORE® TAG® and Conformable GORE® TAG® 
Thoracic Endoprostheses at 5 years, on a cohort of patients representative of the 
population treated under real-life conditions.  
 
2.2 
 Endpoint criteria 
2.2.1  Primary endpoint criteria 
The primary endpoint will be:  
• 
The all-cause mortality rates over the long term, that is 5 years  
 
The 5-year mortality is defined for all deaths occurring between the time of surgery when 
the endoprosthesis was inserted into the arterial access and the last follow-up visit at  
5 years. In the absence of a standard population, the primary endpoint will be analyzed 
depending on the urgency of the procedure as defined by the Scientific Committee  
such as: 
• 
Existence of an aortic rupture 
• 
Dissection complicated by malperfusion 

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All data related to the patient's admission, implantation procedure, post-operative 
hospitalization period and follow-up period  (5 years) must be collected.  
Any source document (surgical report, radiological examinations, laboratory tests, death 
certificate, etc.) submitted to the sponsor must be anonymized and bear the patient's 
study identification number.  
 
These forms must be filled out for each patient: 
 1. Pre-operative period 
 To be completed for each patient in order to 
describe his/her medical history and health 
status at the time of admission.  
 2. Implantation 
 To be completed for each patient in order to 
describe the implantation procedure.  
 3. Post-operative period 
 To be completed for each patient in order to 
describe the period between surgery and 
discharge from the hospital. 
 4. Follow-up 
 To be completed for each follow-up visit 
(post-operative visit, follow-up at 1, 2, 3, 4 
and 5 years). An intermediate follow-up 
form must be filled out for any additional 
assessment of either the patient or the 
endoprosthesis.  
 5. Exiting the observational 
study 
 To be filled out for each patient at the 
completion of the study and at the end of 
data collection or to document any 
premature termination of the follow-up visits 
(patient lost to follow-up, patient's death, 
withdrawal of consent, etc.). 
 
 
 
 
Forms to be completed at the onset of an event 
 6. Occurrence of a Serious  
    Adverse Event 
 To be filled for each patient at the onset of 
a serious adverse event (see GCP/ICH) 
 
 7. Repeat intervention 
 To be filled out during any repeat vascular 
intervention (secondary endovascular or 
surgical procedure). 
 8. Complication 
 To be completed at the onset of a 
complication (see paragraph E3). 
 
 

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Table 2 summarizes all the data that will be collected as part of this prospective 
observational study. This is not an exhaustive list. Please refer to the final electronic 
Case Report Form (eCRF).  
Provided the patient has consented to the collection of his or her medical data by signing 
an informed consent form, a registry of patients treated with an endoprosthesis but not 
included in the study will be established at each participating center to document the 
following information: reason for non-inclusion, age, gender, presence of a life-
threatening emergency, main indication for implantation and date of implantation. For 
patients who refused the collection of their personal data, only the reason for  
non-inclusion and the date of implantation will be documented. 
A general form could be created for this purpose in the case report form that must be 
completed by the investigator throughout the study for each patient who was eligible but 
not included.  
 
5.3 
Adverse events 
According to the primary and secondary endpoints of this study, the documentation of 
the adverse events shall consist of:  
Adverse events related to the device and the procedure, regardless of their severity 
(severe side effects or not) 
serious adverse events such as: 
o Pulmonary complications 
o Neurological complications of the central and peripheral nervous systems 
o Vascular complications 
o Cardiac complications 
o Renal complications 
o Visceral complications 
o Infectious complications 
o Any complication resulting in the patient's death 
Imaging abnormalities, the notes/technical facts behind the clinical outcomes 
These complications must be documented throughout the study; they will appear in the 
patient's medical record and will be collected in the form of Serious Adverse Events in 
the electronic Case Report Form. This form must be completed for each adverse event 
specific to the study, regardless of the severity or causality of the event. The information 
contained in this form shall include, among others, a description of the event, the date of 
occurrence of the event, the causal link with the device, the procedure, the measures 
taken and the evolution of the event.  
 
Once informed, the investigator shall immediately send a comprehensive report of these 
complications to W.L. Gore & Associates, Inc. via the electronic data collection case 
report form, or eCRF.   
 
 
 
 

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5.4 
End of patient participation 
5.4.1 Procedure to withdraw from the study 
The withdrawal procedure from the study applies when patient data are no longer 
collected. Discontinuation of patient data collection will occur in the following cases: 
• 
The patient decides to withdraw from the study at any time, for whatever reason, 
without having to justify such a decision 
• 
Decision made by the doctor to stop the patient's participation in the study in 
order to protect the patient's well-being  
• 
Patient lost to follow-up 
 
Note: the patient may not be considered as being lost to follow-up by the 
investigator as long as the follow-up period (5 years) has not elapsed. 
• 
Patient's death 
• 
Normal end of the observational study 
 
Data on patients, for whom the study endoprosthesis was introduced at the arterial 
access but not inserted during the initial intervention (failed installation), will be collected 
until the patient's withdrawal. Thereafter, a withdrawal form from the observational study 
must be completed.  
 
Patients for whom the endoprosthesis will be explanted during the follow-up period 
should be evaluated clinically at least until the last 5-year visit.  
 
5.4.2 Patients lost to follow-up 
Several measures are taken to avoid patients from being lost to follow-up. The 
observational study documents handed over to investigators during the study set-up 
highlight the fundamental importance of patient follow-up and data collection throughout 
the study. The investigator will seek the means to contact the attending physician or the 
nearest trusted relation. 
In the event of a missed visit, the  investigation center shall contact the patient by phone 
several times (at least two documented calls) and send an appointment letter by certified 
mail. In the absence of a response, the attending physician will be contacted in a bid to 
obtain information on the patient's status and on all elements needed to trace a possible 
endoprosthesis related clinical event (hospitalization, surgery, etc.). 
In the event that there are no results from the procedures below, then the alive/dead 
status of the patient must be documented in the eCRF once the investigator has 
confirmed it from the Epidemiological Center for the Medical Causes of Death  
(Cépi-DC). 
Note: the patient may not be considered lost to follow-up by the investigator as long as 
the follow-up period (5 years) has not elapsed.  
 
5.5 
Deviations from the Clinical Investigation Plan 
A deviation from the observational study (deviation from the protocol) occurs when the 
investigator or a member of the center involved in the observational study does not 
conduct the study according to the Clinical Investigation Plan, or according to existing 
regulations.  

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7 
LEGAL & ETHICAL CONSIDERATIONS  
 
7.1 
CNIL [French Data Protection Agency] Declaration 
This observational study shall be subject to the modified version of the Data Protection 
law of January 6, 1978. Before its actual commencement, the processing of data 
collected in the observational study shall be subject to referral to the French Advisory 
Committee on Information Processing in Material Research in the Field of Health 
(CCTIRS), and then the French Data Protection Agency (CNIL). 
 
7.2 
Information and Non-opposition Form 
The investigator must inform the patient about the nature and objectives of the data 
collection and answer all questions. Patients must be informed of their rights, prior to 
their enrollment in the study, in order to be able to refuse, if they so wish, the collection 
and transmission of personal data.  
According to existing law, an informational note must be given to the patient and an 
informed consent must be signed by the patient in order to collect and transmit his/her 
personal medical data.  
 
7.3 
Final Research Report 
The final research report will be written by the sponsor. This report will be sent to each of 
the investigators.  
 
 
8 
DATA PROCESSING AND STORAGE OF RESEARCH 
RELATED DOCUMENTS AND DATA 
 
Documents pertaining to research must be stored by all parties involved for a period of 
15 years after the end of the research. 
 
This indexed storage will comprise at least: 
• 
Successive versions of the protocol (identified by the version No. and date) 
• 
The letters of correspondence with the manager 
• 
A completed and validated case report form for each subject enrolled 
• 
All appendices specific to the observational study 
• 
The final report of the observational study 
  
The database from which the statistical analysis was drawn must also be stored by the 
head of analysis (hard or soft copy).  
 
 
 

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9.6 
Rules relating to publication  
W. L. Gore & Associates, Inc. is the proprietor of all data, analyses and results relating to 
the GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis and these 
may not be used or transmitted to a third party without prior consent therefrom.  
However, the center is free to independently use and develop data resulting from the 
medical records of its own patients, as also data and information: 
• 
That were known to the center prior to its disclosure by manufacturers 
• 
That are or become legally accessible to the public 
• 
That are released from the seal of confidentiality by written agreement of the 
manufacturer 
 
 
10 
EXPECTED RISKS AND BENEFITS 
10.1 Risks 
This study does not lead to any change in patient management. Therefore, there is no 
additional risk to the patients from their participation in the study.  
Risks related to the implantation of a thoracic endoprosthesis, specifically the 
implantation of GORE® TAG® and Conformable GORE® TAG® Thoracic 
Endoprostheses have been described in the User's Manual delivered with each device. 
 
10.2 Benefits 
Patients in this observational study will receive the same treatment as they would have 
received if they had decided not to participate in this study. Therefore, there is no direct 
benefit related to their participation in the study.  
  
 

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11 
BIBLIOGRAPHICAL REFERENCES 
1 - Evaluation of endoprostheses in the treatment of aneurysms and dissections of the 
thoracic aorta. HAS report. February 2006 
2 - Opinion of the National Assessment Committee for Medical Devices and Health 
Technologies, Valiant with CAPTIVIA installation system. Opinion of December 22, 2009 
3 - Brandt M et al. Stent-graft repair versus open surgery for the descending aorta: a 
case-control study. J Endovasc Ther 2004; 11(5): 535-8 
4 - Evaluation of abdominal aortic endoprostheses used for the treatment of aneurysms 
of the abdominal infrarenal aorta. Afssaps/HAS Report. July 7, 2009