ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection
Conditions: Aortic Dissection
Sponsor: W.L.Gore & Associates

ARISE: Evaluation of the GORE® Ascending Stent Graft in 
the Treatment of DeBakey Type I/II Aortic Dissection 
(TBE 14-02) 
NCT02380716 
Protocol V7 Approval Date: 15 Sept 2020 
Statistical Analysis Plan Date: 09 Jun 2021 

 CONFIDENTIAL INFORMATION 
 
Page 1 of 4 
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. 
 
 
 
 
ARISE: Evaluation of the GORE® Ascending Stent Graft in the  
Treatment of DeBakey Type I/II Aortic Dissection 
 
Protocol Number: 
 
TBE 14-02 
 
 
 
 
Amendment 7 
 
15 Sept 2020 
 
 
 
W. L. Gore & Associates, Inc. 
Medical Products Division 
 
 

 CONFIDENTIAL INFORMATION 
 
Page 2 of 4 
MD133246 Protocol Template 
Revision#: 2 
Doc Type: GC 
PROTOCOL SUMMARY 
 
Study Title 
ARISE: Evaluation of the GORE® Ascending Stent Graft in 
the Treatment of DeBakey Type I/II Aortic Dissection 
Protocol Number 
TBE 14-02 
  
IDE or PMA Number  
G140230 
Sponsor 
W. L. Gore & Associates, Inc.  
Medical Products Division 
Telephone: 800-437-8181 
Study Design 
Prospective, multicenter, non-randomized, single arm study  
Study Objective 
Assess the feasibility of the treatment of DeBakey Type I/II 
aortic dissections with the GORE® Ascending Stent Graft  
Study Endpoints 
Primary Endpoint:  
• 
All-cause mortality at 30 days post-procedure 
 
Secondary Endpoints:  
• 
Successful dissection treatment (technical success), to 
include: 
o Successful access to the aorta (transfemoral or 
retroperitoneal) 
o Successful delivery of all required device 
components to the aorta and/or branch vessel 
o Successful deployment of all required device 
components in their intended location 
o Successful retrieval of device delivery system 
o Exclusion of the primary entry tear of the aortic 
dissection based on completion angiography 
o Patent Side Branch Component (if used as part of 
primary procedure) based on completion 
angiography 
• 
Major Adverse Cardiovascular and Cerebrovascular 
Event (MACCE) assessed through 30 days, 6 months, 
and 12 months 
• 
Individual MACCE components through 30 days, 6 
months, and 12 months 
• 
Aorta related mortality 
• 
Device migration assessed through 1 month, 6 months, 
and 12 months  
• 
Endoleak assessed through 1 month, 6 months, and 12 
months  
Subject Population 
Subjects with DeBakey Type I/II aortic dissection allowing 
for treatment with the GORE® Ascending Stent Graft, 
including: 
• 
Primary entry tear must be in the ascending aorta 
and ≥2cm distal to the most distal coronary artery 
ostia 

 CONFIDENTIAL INFORMATION 
 
Page 3 of 4 
MD133246 Protocol Template 
Revision#: 2 
Doc Type: GC 
• 
Ascending aorta compatible with the GORE® 
Ascending Stent Graft including landing zone true 
lumen diameter between 27mm – 42mm and total 
aortic landing zone diameter ≤ 45 mm 
Number of Subjects 
Up to 30 subjects  
Number of Sites 
Up to 9 sites in the U.S. 
Significant Inclusion 
Criteria 
• 
DeBakey Type I/II aortic dissection compatible with the 
treatment requirements of the GORE® Ascending Stent 
Graft, including: 
o Primary entry tear must be in the ascending aorta 
and  ≥2cm distal to the most distal coronary 
artery ostia 
o Ascending aorta compatible with the GORE® 
Ascending Stent Graft including landing zone 
true lumen diameter between 27mm – 42mm and 
total aortic landing zone diameter ≤ 45 mm 
• 
Able to undergo CT scan per protocol requirements to 
perform required case planning prior to endovascular 
procedure 
• 
High surgical risk, as determined by the implanting 
physician 
• 
An Informed Consent Form signed by subject or legally 
authorized representative  
Significant Exclusion 
Criteria 
• 
Planned aortic valve repair or replacement or coronary 
artery intervention within 30 days 
• 
Presence of mechanical heart valve in the aortic position 
• 
Primary entry tear location in the aortic arch or 
descending thoracic aorta with retrograde flow into the 
ascending aorta 
• 
Aortic insufficiency grade 3+ or 4+  
• 
Life expectancy <12 months due to associated non-
cardiac co-morbid conditions 
Expected Time to 
Complete Enrollment  
• 
Subject accrual: 2 years 
• 
Follow-up: 5 years from last subject enrollment 
• 
Total study duration: 7 years 
Schedule of Events 
• 
Screening: Surgical Risk Assessment, Spiral CTA of 
chest, abdomen and pelvis (Retrospective cardiac-gated 
CTA Scan optional), Physical Exam, Serum Creatinine, 
SF-36® Questionnaire, Transthoracic Echocardiogram 
and Modified Rankin Scale 
• 
Procedure: Endovascular procedure with post-treatment 
Angiogram and Transesophageal Echocardiogram  
• 
Post-procedure: Transthoracic or Transesophageal 
Echocardiogram ≤ 2 hours after procedure end time 

 CONFIDENTIAL INFORMATION 
 
Page 4 of 4 
MD133246 Protocol Template 
Revision#: 2 
Doc Type: GC 
• 
Discharge: Physical Exam, Transthoracic 
Echocardiogram and Modified Rankin Scale 
• 
1 month and 6 months post-treatment: Retrospective 
cardiac-gated CTA Scan with ≥10 cardiac phases of 
chest, Physical Exam, SF-36® Questionnaire, 
Transthoracic Echocardiogram and Modified Rankin 
Scale 
• 
Modified Rankin Scale also completed at 90 days for 
subjects suspected of experiencing a stroke event 
through 30 days  
• 
12 month post-treatment: Retrospective cardiac gated 
CTA Scan of chest, SF-36® Questionnaire, 
Transthoracic Echocardiogram and Physical Exam 
• 
24, 36, 48, and 60 months post treatment: Spiral CTA of 
chest (Cardiac Resolved CT Scan optional), Physical 
Exam, and SF-36® Questionnaire 
 

MD139367 TBE 14-02 SAP Revision# 4 Doc Type SP 
 
CONFIDENTIAL INFORMATION 
MD133254 Statistical Analysis Plan Template 
Revision#: 1 
 
Page 1 of 17 
Doc Type: GC 
 
 
 
 
 
 
 
 
 
 
Statistical Analysis Plan 
 
ARISE: Evaluation of the GORE® Ascending Stent Graft in the 
Treatment of DeBakey Type I/II Aortic Dissection 
 
Study Acronym/Protocol #: TBE 14-02 
 

MD139367 TBE 14-02 SAP Revision# 4 Doc Type SP 
 
CONFIDENTIAL INFORMATION 
MD133254 Statistical Analysis Plan Template 
Revision#: 1 
 
Page 2 of 17 
Doc Type: GC 
 
 
Table of Contents 
 
 
1.0 
Introduction ...................................................................................................................................... 4 
2.0 
Study Design Overview ................................................................................................................... 4 
2.1 
Objectives ............................................................................................................................ 4 
2.1.1 
Primary Objective(s) 
4 
2.2 
Design Summary ................................................................................................................. 4 
2.3 
Study Endpoints .................................................................................................................. 4 
2.3.1 
Primary Endpoint 
4 
2.3.2 
Secondary Endpoints 
4 
2.3.3 
Endpoint Definitions 
5 
2.4 
Statistical Hypotheses ......................................................................................................... 6 
2.5 
Sample Size Assumptions ................................................................................................... 6 
2.6 
Sample Size Calculations .................................................................................................... 6 
3.0 
Study Treatment Arms ..................................................................................................................... 6 
3.1 
Test Arm .............................................................................................................................. 6 
3.2 
Control Arm ......................................................................................................................... 6 
4.0 
Study Data Collection ...................................................................................................................... 6 
4.1 
Data Collected ..................................................................................................................... 6 
4.2 
Follow-up windows .............................................................................................................. 7 
4.3 
Schedule of Events.............................................................................................................. 7 
4.4 
Data Safety Monitoring Board ............................................................................................. 9 
4.5 
Clinical Events Committee................................................................................................... 9 
4.6 
Imaging ................................................................................................................................ 9 
5.0 
Statistical Analyses .......................................................................................................................... 9 
5.1 
Analysis Populations ........................................................................................................... 9 
5.2 
Timing of Analyses .............................................................................................................. 9 
5.3 
Analyses Supporting Primary Objective(s) ........................................................................ 10 
5.3.1 
Primary Endpoint 
10 
5.3.2 
Secondary Endpoint – Technical Success 
10 
5.3.3 
Secondary Endpoint – MACCE 
10 

MD139367 TBE 14-02 SAP Revision# 4 Doc Type SP 
 
CONFIDENTIAL INFORMATION 
MD133254 Statistical Analysis Plan Template 
Revision#: 1 
 
Page 3 of 17 
Doc Type: GC 
5.3.4 
Secondary Endpoint – Aorta-Related Mortality 
11 
5.3.5 
Secondary Endpoints – Device Migration and Endoleak 
11 
5.4 
Adverse Events ................................................................................................................. 11 
5.4.1 
Adverse Event Relationship 
12 
5.4.2 
Adverse Event Classification 
12 
5.4.3 
Adverse Event Reporting and Coding 
12 
5.4.4 
Subject Death 
13 
5.5 
Additional Analyses ........................................................................................................... 13 
5.5.1 
Sensitivity Analysis of Endpoint Results 
13 
5.5.2 
Subgroup Analysis 
13 
5.5.3 
Imaging Analysis 
13 
5.5.4 
Mortality 
14 
5.5.5 
Reintervention 
14 
5.5.6 
Device Events 
14 
5.5.7 
Site Data Pooling 
14 
6.0 
Interim Analyses and Safety Monitoring Analyses (if applicable) .................................................. 14 
7.0 
Analysis Specifications .................................................................................................................. 15 
7.1 
SAS Analysis Dataset Specifications ................................................................................ 15 
7.2 
Statistical Output Specifications ........................................................................................ 15 
7.3 
Verification Level for Statistical Output .............................................................................. 15 
8.0 
Data Sets, Tables, Figures, and Listings ....................................................................................... 16 
8.1 
Analysis Tables ................................................................................................................. 16 
8.2 
Analysis Listings ................................................................................................................ 16 
8.3 
Analysis Figures ................................................................................................................ 16 
9.0 
References .................................................................................................................................... 17 
 
 
 
 
 
 
 

MD139367 TBE 14-02 SAP Revision# 4 Doc Type SP 
 
CONFIDENTIAL INFORMATION 
MD133254 Statistical Analysis Plan Template 
Revision#: 1 
 
Page 4 of 17 
Doc Type: GC 
 
 
 
1.0 
Introduction 
This Statistical Analysis Plan (SAP) describes the statistical analyses planned to address the 
objectives of the evaluation of the GORE® Ascending Stent Graft in the treatment of DeBakey 
Type I/II aortic dissections (TBE 14-02).  
2.0 
Study Design Overview 
2.1 
Objectives 
2.1.1 
Primary Objective(s) 
1. To assess the feasibility of treating DeBakey Type I/II aortic dissections with the GORE® 
Ascending Stent Graft 
2. Refine patient selection for future clinical investigations 
3. To estimate boundary conditions in DeBakey Type I/II aortic dissection patients which can be 
used for subsequent device development efforts including: 
o  Aortic compliance 
o  Cardiac and respiratory motion 
2.2 
Design Summary 
This study is a prospective, multicenter, non-randomized single-arm study to assess the feasibility 
of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft 
Device.  
 
A maximum of 9 Clinical Investigative Sites (referred to as “Sites” in the remainder of this 
document) in the United States will participate in this study.  A total of 30 patients will be enrolled 
in this study.   
 
Patients may be enrolled into the study provided all inclusion and no exclusion criteria are met as 
specified in Section 4 of the study Protocol.  
 
2.3 
Study Endpoints 
2.3.1 
Primary Endpoint 
The primary endpoint is all cause mortality through 30 days post-procedure. 
2.3.2 
Secondary Endpoints 
Secondary endpoints include the following: 
• Successful dissection treatment (technical success), to include: 
o Successful access to the aorta (transfemoral or retroperitoneal) 
o Successful delivery of all required device components to the aorta and/or branch vessel 
o Successful deployment of all required device components in their intended location 

MD139367 TBE 14-02 SAP Revision# 4 Doc Type SP 
 
CONFIDENTIAL INFORMATION 
MD133254 Statistical Analysis Plan Template 
Revision#: 1 
 
Page 9 of 17 
Doc Type: GC 
 
4.4 
Data Safety Monitoring Board 
See Section 9.3 of the study Protocol. 
4.5 
Clinical Events Committee 
See Section 9.4 of the study Protocol. 
4.6 
Imaging 
 
 
5.0 
Statistical Analyses 
5.1 
Analysis Populations 
All enrolled Subjects with an attempted initial procedure (have non-missing initial procedure date) 
will be included in analysis as follows:   
• Primary Endpoint: all Subjects will be included; Subjects without known mortality status 
through 30-days will be considered failures for this (i.e. assumed dead for the primary 
endpoint analysis).  
• Secondary Endpoint of technical success: all Subjects will be included; any Subject 
missing evaluation on this will be counted as a failure for this endpoint. 
• Secondary Endpoint (MACCE, MACCE components, and aorta-related mortality):  all 
Subjects will be included. 
• Secondary Endpoints (device migration, endoleak): Subjects with known status (have 
had imaging done or endpoint event reported) at each follow-up window will be included; 
an endpoint event (endpoint failure) will be reported from a Site-reported adverse event.  
Subjects without imaging reported in a window but with an adverse event meeting the 
endpoint definition in a window will count as having an endpoint event for that window.  
Subjects without imaging reported in a window and with no endpoint event reported in 
window will not count towards the denominator for that window. 
5.2 
Timing of Analyses 
Analysis of the study results will be ongoing throughout enrollment.  Regular case review by the 
Data and Safety Monitoring Board (DSMB) and Sponsor will occur throughout enrollment.  
DSMB data review will be instituted as follows: 
• 
For the first four (4) Subjects, procedural reports will be provided to FDA and the 
DSMB Chairman within 5 working days of endovascular treatment and will include 
available procedural narratives, reports and any preliminary Adverse Events (AEs.  
• 
Reporting Subject and device performance data to the DSMB following the 
endovascular treatment of every two (2) Subjects through patient 20 and every five 
(5) patients for patient 20-30, including the available 1 month follow-up visit data for 
preceding cohorts.  

MD139367 TBE 14-02 SAP Revision# 4 Doc Type SP 
 
CONFIDENTIAL INFORMATION 
MD133254 Statistical Analysis Plan Template 
Revision#: 1 
 
Page 11 of 17 
Doc Type: GC 
5.3.4 
Secondary Endpoint – Aorta-Related Mortality 
The aorta-related mortality endpoint (see Endpoint Definitions Section 2.3.3) will be determined 
by CEC adjudication using a specific question asked on the CEC CRF. 
 
For analysis of the aorta-related mortality endpoint, Kaplan Meier methodology will be used to 
estimate the aorta-related mortality rate through the following specified time intervals: 30 days, 
180 days (6 months), and 365 days (12 months) and annually thereafter. Subjects without an 
aorta-related death reported before the end of the time period of interest will be censored at the 
Subject’s last reported contact date or the end of the time period of interest, whichever date is 
earlier. 
5.3.5 
Secondary Endpoints – Device Migration and Endoleak 
Tables (one for device migration and one for endoleak) will be prepared with time intervals and 
the incident event rate will be reported in each time interval window (using either the 
corresponding imaging date or adverse event onset date).  Denominators for the time windows 
will be as specified in Section 5.1. An endpoint event (endpoint failure) will be reported from a 
Site-reported adverse event meeting the endpoint definitions. Time intervals for these tables will 
be the analysis windows shown in Table 1. In addition, endoleak rates will also be reported by 
endoleak type.   
5.4 
Adverse Events 
Adverse events (AEs) will be summarized for main reporting efforts. Adverse events are defined 
as any untoward medical occurrences in a Subject whether device-related or not. All AEs will be 
recorded on the appropriate CRF and documented in the Subject’s permanent medical record.  
The Investigator at each Site is ultimately responsible for reporting all AEs to the Sponsor, as well 
as to the IRB, as applicable.   
 
Adverse events will be summarized by incidence (i.e. a specific AE will not be counted more than 
once for a Subject within each window) in each analysis time window for each Subject. The 
denominator for each window will be calculated as the number of enrolled Subjects remaining in 
follow-up as of the beginning of the analysis window (Subjects must have an initial procedure 
date).  At a minimum, separate summaries by AE relationship and severity will be prepared.   
 
Partial dates (month and/or day unknown) for AE onset and AE resolution dates will be allowed 
for analysis.  Exact imputation logic will be documented in the appropriate specifications 
document.  In general, partial dates will be imputed to be most conservative with regards to timing 
after initial procedure date. 
 
Selected AEs will be reviewed by the independent CEC and adjudicated with regard to device 
and/or procedure relationship and severity. Specific AEs of clinical interest in this Subject 
population will include, but are not limited to: death-related AEs, stroke, paraplegia/paraparesis, 
and MACCEs. Reported AEs which potentially meet the definition of AEs of clinical interest will be 
referred to the CEC for review and adjudication to the study Protocol’s definitions provided for 
these events. The adjudicated opinion of the CEC will also be used in analysis and reporting of 
adverse event data.  

MD139367 TBE 14-02 SAP Revision# 4 Doc Type SP 
 
CONFIDENTIAL INFORMATION 
MD133254 Statistical Analysis Plan Template 
Revision#: 1 
 
Page 12 of 17 
Doc Type: GC 
5.4.1 
Adverse Event Relationship 
Each reported AE will be assessed by the Investigator for its primary suspected relationship to 
the device or procedure. If the Site-reported primary relationship of the AE is any of the following 
it will be considered a (Site-reported) device and/or procedure related AE:  related to device, 
related to procedure, or related to device and procedure.  
 
Relationships include: 
 
Related to device  
The functioning or characteristics of the device caused or contributed to the AE. 
Related to device and procedure 
The device AND the endovascular procedure caused or significantly contributed to the AE. 
Related to procedure 
The endovascular procedure (and not the device) caused or significantly contributed to the AE. 
Related to other procedure 
Other procedure performed caused or significantly contributed to the AE. 
Related to disease 
Original (treated) disease caused or significantly contributed to the AE. 
Not-related 
An AE which cannot be attributed to the device or procedure. 
Unknown relationship 
The relationship of the AE to the device or procedure cannot be determined.  
5.4.2 
Adverse Event Classification 
Each AE will be assessed by the Investigator to determine if it is serious or non-serious3. 
 
Serious Adverse Event  
An SAE is an AE that 
• Led to death 
• Led to serious deterioration in the health of the Subject 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.  
 
Non-Serious Adverse Event  
Any event that does not meet the definition of serious will be classified as non-serious.   
5.4.3 
Adverse Event Reporting and Coding 
AEs will be reported on the appropriate CRF and documented in the Subject’s permanent medical 
record.  The Investigator at each Site is ultimately responsible for reporting AEs to the Sponsor 
and the IRB, when applicable. The Investigator shall supply the Sponsor and IRB with any 
additional requested information. AE reporting for a Subject begins once the Subject is enrolled in 
the study through study completion/withdrawal.