Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

Study Overview
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Brief Summary
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The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.

Detailed Description
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The study design is a prospective, nonrandomized, international, multicenter study comprised of two parallel substudies. The total subject population will be 190 subjects with 80 subjects assigned to the Short Neck Substudy and 110 subjects to the High Neck Angulation Substudy. This clinical study will include fifty-six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams and contrast-enhanced computed tomography (CT) scans at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Conformable AAA Endoprosthesis implant. Each Substudy will be evaluated and reported independently from each other according to the Safety and Effectiveness Endpoints. No comparative analyses between these substudies are planned.

Official Title
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Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

Conditions
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Aortic Aneurysm, Abdominal

Intervention / Treatment
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* Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis


Participation Criteria
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Eligibility Criteria
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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 GORE® EXCLUDER® Conformable AAA Endoprosthesis, 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 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 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short Neck Substudy<br>Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis. | Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis<br>* Endovascular Aneurysm repair (EVAR) is a minimally invasive procedure designed to exclude an aneurysmal segment of the aorta from blood circulation. The EVAR procedure involves delivery of a stent- graft compressed onto a catheter to an aneurysmal segment of the aorta from a remote access site, generally the femoral artery. Arterial access may be done by either percutaneous or cut-down technique.<br>|
| Experimental: High Neck Angulation Substudy<br>Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation > 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis. | Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis<br>* Endovascular Aneurysm repair (EVAR) is a minimally invasive procedure designed to exclude an aneurysmal segment of the aorta from blood circulation. The EVAR procedure involves delivery of a stent- graft compressed onto a catheter to an aneurysmal segment of the aorta from a remote access site, generally the femoral artery. Arterial access may be done by either percutaneous or cut-down technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by a composite of Adverse Events | Composite of the following: Death Stroke Myocardial Infarction Bowel Ischemia Paraplegia Respiratory Failure Renal Failure Procedural Blood Loss > 1000 mL Thromboembolic events (including limb occlusion and distal embolic events) | 30 Days | 
| Effectiveness as measured by a composite of Adverse Events | Composite of technical success (successful access and deployment of all required GORE® EXCLUDER® Conformable AAA Endoprosthesis components) and freedom from: Type I endoleak in the 12 month window Type III endoleak in the 12 month window Migration (10 mm or more) between the one month and at the 12 month window AAA enlargement ≥5 mm with or without intervention between the one month and the 12 month window AAA rupture through the 12 month window Conversion to open repair through the 12 month window | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintervention | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Stent fracture based on core lab analysis | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Type II endoleak | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Aneurysm-related mortality | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Index Procedure Blood Loss | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Type IV endoleak | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Length of Hospital Stay (initial hospitalization) | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Index Procedure Time | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Stroke | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Myocardial Infarction | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Bowel Ischemia | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Paraplegia | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Death | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Renal Failure | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Respiratory Failure | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Thromboembolic events (including limb occlusion and distal embolic events) | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Type I endoleak | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Type III endoleak | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Migration (10 mm or more) | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Procedural Blood Loss > 1000 mL | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| AAA enlargement ≥5 mm with or without intervention | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| AAA rupture | Effectiveness as measured by a composite of Adverse Events | 12 Months | 
| Conversion to open repair | Effectiveness as measured by a composite of Adverse Events | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic aneurysm, Abdominal aorta, Stent graft, Aneurysm, Vascular Diseases, Cardiovascular Diseases