Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Sponsor: W.L.Gore & Associates

  GORE® EXCLUDER® Conformable AAA Endoprosthesis 
 
 
CONFIDENTIAL INFORMATION 
 
 
 
 
 
 
Nothing herein is to be disclosed in any way without the prior 
express written permission of W. L. Gore & Associates, Inc. 
 
Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of 
Abdominal Aortic Aneurysms  
 
 
Protocol number: 
AAA 13-03 
 
 
 
                                                                     07September2022 
 
 
 
 
 
 
 
 
W. L. Gore & Associates, Inc. 
Medical Products Division 

  GORE® EXCLUDER® Conformable AAA Endoprosthesis 
 
 
CONFIDENTIAL INFORMATION 
 
 
 
 
PROTOCOL SUMMARY 
Study Title 
Assessment of the GORE® EXCLUDER® Conformable AAA 
Endoprosthesis (CEXC Device) in the Treatment of 
Abdominal Aortic Aneurysms 
Protocol Number 
AAA 13-03 
 
 
 
 
 
 
 
 
 
 
IDE or PMA Number  
IDE # G150057 
Sponsor 
W. L. Gore & Associates, Inc. 
 
 
 
Telephone: 800-437-8181 
 
Study Design 
Prospective, nonrandomized, multicenter, study with two 
parallel substudies: 
Short Neck Substudy: Subjects with abdominal aortic 
aneurysms having aortic neck angulation ≤ 60˚ and 
infrarenal aortic neck length ≥ 10 mm 
High Neck Angulation Substudy: Subjects with abdominal 
aortic aneurysms having aortic neck angulation > 60 ˚and ≤ 
90˚ and infrarenal aortic neck length  ≥ 10 mm 
Study Objective 
Assess the safety and effectiveness of the CEXC Device for 
the treatment of infrarenal AAA 
Primary Safety 
Endpoint (Both 
Substudies) 
 
• 
Composite of any of the following events through 30 
days post-treatment: 
• 
Death 
• 
Stroke  
• 
Myocardial Infarction  
• 
Bowel Ischemia 
• 
Paraplegia  
• 
Respiratory Failure  
• 
Renal Failure  
• 
Blood Loss > 1000 mL 
• 
Thromboembolic Events (including limb occlusion 
and distal embolic events) 

  GORE® EXCLUDER® Conformable AAA Endoprosthesis 
 
 
CONFIDENTIAL INFORMATION 
 
 
 
 
Primary Safety 
Endpoint Hypothesis 
(Both Substudies) 
Percentage of subjects free from safety events as 
adjudicated by the Clinical Events Committee (CEC) at 30 
days will be > 79% 
Primary Effectiveness 
Endpoint (Both 
Substudies) 
Treatment success, defined as technical success (defined 
as successful access and deployment of all required CEXC 
Device components) and freedom from the following events: 
• 
Type I endoleak 
• 
Type III endoleak 
• 
Migration (10 mm or more)  
• 
AAA enlargement ≥ 5 mm with or without intervention 
• 
AAA rupture  
• 
Conversion to open repair 
Primary Effectiveness 
Endpoint Hypothesis 
(Both Substudies) 
The percentage of subjects with treatment success at one 
year will be > 80% 
Subject Population 
Subjects with infrarenal abdominal aortic aneurysm (AAA) 
Number of Subjects 
Initial Cohort: A total of 175 subjects: 
80 Short Neck Substudy, 95 High Neck Angulation Substudy 
Continued Enrollment Cohort (optional): Up to 15 High Neck 
Angulation Subjects. 
Number of Sites 
A maximum of 56 sites located in the U.S.  
 
The Sponsor shall maintain an updated list of principal 
investigators, investigational sites, and institutions. This list 
shall be kept separately from this Protocol.  
Expected Time to 
Complete Enrollment 
Subject accrual – 2 years  
Follow-up –  5 years from last subject enrollment 
Total investigation duration – 10 years 
(including site initiation and closing period) 
Expected Time of each 
Study Subject to 
Complete the Study 
Total of 60 months for each subject to complete the study 
Pre-Treatment 
Evaluation 
• 
Physical exam / medical history within 30 days of 
procedure 
• 
Serum creatinine concentration 
• 
Contrast enhanced spiral CT of the abdomen and 
pelvis ≤ 90 days from procedure 
Follow-Up Evaluations 
Follow-up conducted at one, six, and twelve months post-
treatment and annually thereafter for five years to consist of: 
• 
Physical examination 
• 
Contrast enhanced CT scan  
• 
Non-contrast CT scan (1 month only) 

  GORE® EXCLUDER® Conformable AAA Endoprosthesis 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
Significant Inclusion 
Criteria 
AAA meeting any of the following criteria: 
• 
Maximum diameter ≥ 50 mm 
• 
Rapid growth (> 5 mm in a 6 month period) 
• 
Non-ruptured AAA presenting with clinical symptoms 
• 
Adequate anatomy to receive the CEXC Device, 
including: 
• 
Adequate iliac / femoral access 
• 
Infrarenal aortic neck diameter 16-32 mm 
• 
Infrarenal aortic neck length ≥ 10 mm  
• 
Aortic neck angle ≤ 90˚ 
• 
Distal iliac artery seal zone ≥ 10 mm 
• 
Iliac artery diameter 8-25 mm  
• 
An Informed Consent Form (ICF) signed by subject  
• 
Male or infertile female*  
• 
Able to comply with Protocol requirements including 
following-up 
• 
Life expectancy > 2 years 
• 
Age ≥ 21 years  
• 
* Infertile female – condition which prevents 
pregnancy, e.g., hysterectomy, tubal ligation or post-
menopausal for greater than 1 year 
• 
Subjects will be allocated to the appropriate 
substudy based on the aortic neck angle 
measurement recorded during screening. 
Significant Exclusion 
Criteria 
• 
Mycotic or ruptured aneurysm 
• 
Known concomitant thoracic aortic aneurysm which 
requires surgical intervention 
• 
Renal insufficiency defined as creatinine > 2.5 mg / 
dL or patient undergoing dialysis 
• 
New York Heart Association (NYHA) class IV 
• 
Aneurysmal, dissected, heavily calcified, or heavily 
thrombosed landing zone(s) 
• 
Severely tortuous or stenotic iliac and / or femoral 
arteries  
• 
Patient has body habitus or other medical condition 
which prevents adequate delineation of the aorta  
• 
Participating in another investigational device or drug 
study within 1 year of treatment 

  GORE® EXCLUDER® Conformable AAA Endoprosthesis 
 
 
CONFIDENTIAL INFORMATION 
 
 
 
 
• 
Systemic infection which may increase the risk of 
endovascular graft infection 
• 
Known degenerative connective tissue disease, e.g., 
Marfan or Ehler-Danlos Syndrome 
• 
Planned concomitant surgical procedure or major 
surgery within 30 days of treatment date  
• 
Known history of drug abuse 
• 
Known sensitivities or allergies to the device 
materials 
Total Expected 
Duration of the Study 
Total investigation duration – 10 years 
(including site initiation and closing period) 
Schedule of Events- 
All Enrolled Subjects 
Screening 
Pre-Treatment 
Treatment 
Discharge 
Follow-up (30 day, 6 and 12 month and annually through 5 
years). 
Data Monitoring 
Committees 
Clinical Events Committee (CEC) 
Data Safety Monitoring Board (DSMB)