Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
- Conditions
- Aortic Aneurysm, Abdominal
- Interventions
- Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis
- Registration Number
- NCT02489539
- Lead Sponsor
- W.L.Gore & Associates
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 175
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Short Neck Substudy GORE® EXCLUDER® Conformable AAA Endoprosthesis 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. High Neck Angulation Substudy GORE® EXCLUDER® Conformable AAA Endoprosthesis 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.
- Primary Outcome Measures
Name Time Method Number of Subjects Free From Primary Safety Endpoint Event 30 Days The primary safety endpoint event includes a 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)Number of Subjects With Device Treatment Success 12 Months The Primary Effectiveness Endpoint of device treatment success is a 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) at the 12 month window (relative to post-operative baseline)
* AAA enlargement ≥5 mm with or without intervention at the 12 month window (relative to post-operative baseline)
* AAA rupture through the 12 month window
* Conversion to open repair through the 12 month window
- Secondary Outcome Measures
Name Time Method Number of Subjects With Abdominal Aortic Aneurysm Rupture 5 years Defined as rupture in the treated segment of the aorta verified with direct observation or CT scan
Number of Subjects With Reintervention 5 years Defined as an adverse event treatment performed to either treat the abdominal aneurysm and/or device-related complication (Adjudicated by independent Clinical Events Committee)
Number of Subjects With Significant Index Procedure Blood Loss Procedure Day Defined as estimated blood loss recorded during the endovascular procedure \> 1000 mL
Number of Subjects With Type I Endoleak 5 years Defined as endoleak arising from the proximal (Type IA) or distal (Type IB) sealing zone of the device perfusing the aneurysm. (assessed by independent 3rd party imaging laboratory)
Number of Subjects With Type IV Endoleak 5 years Defined as Endoleak of whole blood through the graft fabric (Graft Porosity). (assessed by independent 3rd party imaging laboratory)
Number of Subjects With Severe Myocardial Infarction 5 years Defined as myocardial Infarction resulting in severe hemodynamic dysfunction necessitating resuscitation, cardiac arrest, or fatal outcome. (Adjudicated by independent Clinical Events Committee)
Number of Subjects With Type III Endoleak 5 years Defined as endoleak arising from the component junction(s) of the prosthesis or due to damage to the graft material (assessed by independent 3rd party imaging laboratory)
Number of Subjects With AAA Enlargement ≥5 mm 5 years Defined as AAA enlargement ≥5 mm (with or without reintervention) relative to post-operative baseline (assessed by independent 3rd party imaging laboratory)
Number of Subjects With Type II Endoleak 5 years Defined as an endoleak arising from a patent branch vessel perfusing the aneurysm, e.g., lumbar or inferior mesenteric branch. (assessed by independent 3rd party imaging laboratory)
Number of Subjects With Severe Stroke 5 years Defined as stroke resulting in severe impairment or fatal outcome (Adjudicated by independent Clinical Events Committee)
Number of Subjects With Severe Renal Failure 5 years Defined as renal failure resulting in permanent dialysis, transplant, or fatal outcome (Adjudicated by independent Clinical Events Committee)
Number of Subjects With Stent Fracture 5 years Defined as fracture of the wire used to construct the stent (assessed by independent 3rd party imaging laboratory)
Number of Subjects With Aneurysm-related Mortality 5 years Defined as a composite of the following: death within 30 days or in hospital from initial procedure, death due to rupture of the originally treated aneurysm and death within 30 days or in hospital following a procedure to treat the originally treated aneurysm. (Adjudicated by independent Clinical Events Committee)
Median Hospital Stay Through initial hospital discharge Defined as time to discharge for initial procedural hospitalization
Number of Subjects With Severe Paraplegia 5 years Paraplegia resulting in major permanent deficit (Adjudicated by independent Clinical Events Committee)
Number of Subjects With Conversion to Open Repair 5 years Defined as open surgical abdominal aneurysm repair necessitating the explant of the stent-graft and abdominal aortic reconstruction (Adjudicated by independent Clinical Events Committee)
Median Index Procedure Time Procedure Day Defined as time from first arterial access in the groin to the closure of the final access vessel
Number of Subjects With Severe Bowel Ischemia 5 years Defined as bowel Ischemia resulting in bowel resection or fatal outcome (Adjudicated by independent Clinical Events Committee)
Number of Subject Deaths 5 years Defined as death of any cause (all-cause mortality)
Number of Subjects With Severe Respiratory Failure 5 years Defined as respiratory failure resulting in prolonged intubation (\> 48 hours), tracheostomy, deterioration in pulmonary function, new onset O2 dependence, or fatal outcome (Adjudicated by independent Clinical Events Committee)
Number of Subjects With Thromboembolic Events (Including Limb Occlusion and Distal Embolic Events) 5 years Defined as ischemic events from tissues distal to the device implantation site (lower extremity, buttock, etc.) and that are a direct result of an occlusion within the device or sufficiently debilitating to necessitate bypass, open surgical repair, or limb amputation (Adjudicated by independent Clinical Events Committee)
Number of Subjects With Migration 5 years Defined as prosthesis and/or intercomponent migration (10 mm or more) relative to post-operative baseline (assessed by independent 3rd party imaging laboratory)
Median Procedural Blood Loss (mL) Procedure Day Median blood loss at index procedure
Technical Success Procedure Day Successful access and deployment of all required CEXC device components, comprised of all the following:
* Successful access
* Successful deployment of Device endoprostheses in the intended anatomical location
* Successful removal of all device delivery catheters from the patient
* Patent Device components on completion angiography
* Absence of Type I or Type III endoleak on completion angiography
* Successful access site closure
Trial Locations
- Locations (51)
Vascular Surgical Associates, PC
🇺🇸Marietta, Georgia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
The Methodist Hospital - Houston
🇺🇸Houston, Texas, United States
Baptist Cardiac and Vascular Institute
🇺🇸Miami, Florida, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Aurora Health Care, Metro Inc.
🇺🇸Milwaukee, Wisconsin, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
Oklahoma Heart Hospital Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Leland Stanford Junior University
🇺🇸Stanford, California, United States
River City Clinical Research
🇺🇸Jacksonville, Florida, United States
Sarasota Vascular Specialists
🇺🇸Sarasota, Florida, United States
Loyola University - Chicago
🇺🇸Maywood, Illinois, United States
Southern Illinois University
🇺🇸Springfield, Illinois, United States
University of Iowa Hospitals & Clinic
🇺🇸Iowa City, Iowa, United States
Spectrum Health System
🇺🇸Grand Rapids, Michigan, United States
Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Essentia Institute of Rural Health
🇺🇸Duluth, Minnesota, United States
Minneapolis Radiology and Vascular Research Foundation
🇺🇸Plymouth, Minnesota, United States
Washington University School of Medicine - St. Louis
🇺🇸Saint Louis, Missouri, United States
Mercy Research
🇺🇸Saint Louis, Missouri, United States
AHA Hospital Corp.
🇺🇸Morristown, New Jersey, United States
The Hitchcock Foundation
🇺🇸Lebanon, New Hampshire, United States
Research Foundation SUNY Buffalo
🇺🇸Buffalo, New York, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
Moses Cone Memorial Hospital
🇺🇸Greensboro, North Carolina, United States
Good Samaritan Hospital-Cincinnati
🇺🇸Cincinnati, Ohio, United States
Prisma Health-Upstate
🇺🇸Greenville, South Carolina, United States
Sanford Clinic - Clinic Research
🇺🇸Sioux Falls, South Dakota, United States
North Central Heart Institute, Ltd.
🇺🇸Sioux Falls, South Dakota, United States
Texas Heart Institute/Baylor St. Luke's Medical Center
🇺🇸Houston, Texas, United States
University of Tennessee
🇺🇸Knoxville, Tennessee, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
CAMC Health Education and Research Institute, Inc.
🇺🇸Charleston, West Virginia, United States
Inova Cardiology-Fairfax
🇺🇸Virginia Beach, Virginia, United States
Sentara Medical Group
🇺🇸Norfolk, Virginia, United States
University of Wisconsin System
🇺🇸Madison, Wisconsin, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
NC Heart and Vascular Research, LLC
🇺🇸Raleigh, North Carolina, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States