Clinical trial NCT02489539: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Keywords: Aortic aneurysm
Abdominal aorta
Stent graft
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2015-07-03
Enrollment: 175
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Number of Subjects Free From Primary Safety Endpoint Event
timeFrame: 30 Days
measure: Number of Subjects With Device Treatment Success
timeFrame: 12 Months
Secondary outcomes:
measure: Number of Subjects With Reintervention
timeFrame: 5 years
measure: Number of Subjects With Stent Fracture
timeFrame: 5 years
measure: Number of Subjects With Type II Endoleak
timeFrame: 5 years
measure: Number of Subjects With Aneurysm-related Mortality
timeFrame: 5 years
measure: Number of Subjects With Significant Index Procedure Blood Loss
timeFrame: Procedure Day
measure: Number of Subjects With Type IV Endoleak
timeFrame: 5 years
measure: Median Hospital Stay
timeFrame: Through initial hospital discharge
measure: Median Index Procedure Time
timeFrame: Procedure Day
measure: Number of Subjects With Severe Stroke
timeFrame: 5 years
measure: Number of Subjects With Severe Myocardial Infarction
timeFrame: 5 years
measure: Number of Subjects With Severe Bowel Ischemia
timeFrame: 5 years
measure: Number of Subjects With Severe Paraplegia
timeFrame: 5 years
measure: Number of Subject Deaths
timeFrame: 5 years
measure: Number of Subjects With Severe Renal Failure
timeFrame: 5 years
measure: Number of Subjects With Severe Respiratory Failure
timeFrame: 5 years
measure: Number of Subjects With Thromboembolic Events (Including Limb Occlusion and Distal Embolic Events)
timeFrame: 5 years
measure: Number of Subjects With Type I Endoleak
timeFrame: 5 years
measure: Number of Subjects With Type III Endoleak
timeFrame: 5 years
measure: Number of Subjects With Migration
timeFrame: 5 years
measure: Median Procedural Blood Loss (mL)
timeFrame: Procedure Day
measure: Number of Subjects With AAA Enlargement ≥5 mm
timeFrame: 5 years
measure: Number of Subjects With Abdominal Aortic Aneurysm Rupture
timeFrame: 5 years
measure: Number of Subjects With Conversion to Open Repair
timeFrame: 5 years
measure: Technical Success
timeFrame: Procedure Day
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Stanford
country: United States
facility: Leland Stanford Junior University
state: California
city: Jacksonville
country: United States
facility: River City Clinical Research
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Sarasota
country: United States
facility: Sarasota Vascular Specialists
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Marietta
country: United States
facility: Vascular Surgical Associates, PC
state: Georgia
city: Maywood
country: United States
facility: Loyola University - Chicago
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinic
state: Iowa
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health System
state: Michigan
city: Duluth
country: United States
facility: Essentia Institute of Rural Health
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
state: Minnesota
city: Plymouth
country: United States
facility: Minneapolis Radiology and Vascular Research Foundation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine - St. Louis
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Research
state: Missouri
city: Lebanon
country: United States
facility: The Hitchcock Foundation
state: New Hampshire
city: Morristown
country: United States
facility: AHA Hospital Corp.
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Buffalo
country: United States
facility: Research Foundation SUNY Buffalo
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Moses Cone Memorial Hospital
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Hospital-Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital Research Foundation
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health-Upstate
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Clinic - Clinic Research
state: South Dakota
city: Sioux Falls
country: United States
facility: North Central Heart Institute, Ltd.
state: South Dakota
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Texas Heart Institute/Baylor St. Luke's Medical Center
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital - Houston
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Medical Group
state: Virginia
city: Virginia Beach
country: United States
facility: Inova Cardiology-Fairfax
state: Virginia
city: Charleston
country: United States
facility: CAMC Health Education and Research Institute, Inc.
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin System
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Health Care, Metro Inc.
state: Wisconsin
Study officials:
affiliation: Maimonides Medical Center (US)
name: Robert Rhee, MD
role: PRINCIPAL_INVESTIGATOR
References: