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

W.L. Gore & Associates

Status: Active, not recruiting

Conditions: Aortic Aneurysm, Abdominal

Treatments: Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT02489539

AAA 13-03 (1)

Details and patient eligibility

About

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.

Full description

The study design is a prospective, nonrandomized, international, multicenter study comprised of two parallel substudies. The total subject population is 175 subjects with 80 subjects assigned to the Short Neck Substudy and 95 subjects to the High Neck Angulation Substudy.

This clinical study will include up to 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.

Enrollment: 175 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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

2. 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

3. An Informed Consent Form (ICF) signed by Subject

4. Male or infertile female

5. Able to comply with Protocol requirements including following-up

6. Life expectancy > 2 years

7. Age ≥ 21 years

Exclusion criteria

1. Mycotic or ruptured aneurysm
2. Known concomitant thoracic aortic aneurysm which requires surgical intervention
3. Renal insufficiency defined as creatinine > 2.5 mg/dL or patient undergoing dialysis
4. New York Heart Association (NYHA) class IV
5. Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
6. Severely tortuous or stenotic iliac and / or femoral arteries
7. Patient has body habitus or other medical condition which prevents adequate delineation of the aorta
8. Participating in another investigational device or drug study within 1 year of treatment
9. Systemic infection which may increase the risk of endovascular graft infection
10. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
11. Planned concomitant surgical procedure or major surgery within 30 days of treatment date
12. Known history of drug abuse
13. Known sensitivities or allergies to the device materials

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 2 patient groups

Short Neck Substudy

Experimental group

Description:

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.

Treatment:

Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis

High Neck Angulation Substudy

Experimental group

Description:

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.

Treatment:

Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis