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

• ClinicalTrials.gov Identifier: NCT02489539
• Recruitment Status: Recruiting
• First Posted: July 3, 2015
• Last Update Posted: June 16, 2020
• Sponsor: W.L.Gore & Associates
• Information provided by (Responsible Party): W.L.Gore & Associates

Tracking Information

• First Submitted Date: June 22, 2015
• First Posted Date: July 3, 2015
• Last Update Posted Date: June 16, 2020
• Actual Study Start Date: December 19, 2017
• Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 30, 2015)

• Safety as measured by a composite of Adverse Events [ Time Frame: 30 Days ]
  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)
• Effectiveness as measured by a composite of Adverse Events [ Time Frame: 12 Months ]
  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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 30, 2015)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Aortic Aneurysm, Abdominal

Intervention

Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis

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.

Study Arms

• Experimental: Short Neck Substudy
  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.
  Intervention: Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis
• Experimental: High Neck Angulation Substudy
  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.
  Intervention: Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 14, 2015): 190
• Original Estimated Enrollment (submitted: June 30, 2015): 80
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Asia Harris; (623) 234-5668; asharris@wlgore.com

Contact: Rob Lloyd; (928) 864-4052; rlloyd@wlgore.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02489539
• Other Study ID Numbers: AAA 13-03 (1)
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Device and aneurysm status will be communicated to subject through standard of care evaluations. Core Lab data will not be available to subjects.

• Responsible Party: W.L.Gore & Associates
• Study Sponsor: W.L.Gore & Associates
• Collaborators: Not Provided

Investigators

• Principal Investigator: Robert Rhee, MD; Maimonides Medical Center (US)

• PRS Account: W.L.Gore & Associates
• Verification Date: June 2020