Zenith® Low Profile AAA Endovascular Graft

Not Applicable

Completed

Conditions: Iliac Aneurysms
Abdominal Aortic Aneurysms
Aortoiliac Aneurysms

Interventions: Device: Zenith Low Profile AAA Endovascular Graft and ancillary components

Registration Number: NCT02535065

Lead Sponsor: Cook Research Incorporated

Brief Summary: The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aortoiliac, and iliac aneurysms.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 62

Inclusion Criteria

Subject has at least one of the following
- Aortic or aortoiliac aneurysm
- Iliac aneurysm
- Aneurysm with a history of growth

Exclusion Criteria

Less than 18 years of age
Inability or refusal to give informed consent
Disease considerations that would compromise patient safety or study outcomes
Pregnant of breastfeeding or planning on becoming pregnant with 60 months
Unwilling to comply with the follow-up schedule

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endovascular Graft	Zenith Low Profile AAA Endovascular Graft and ancillary components	The Zenith Low Profile AAA Endovascular Graft and ancillary components

Primary Outcome Measures

Name	Time	Method
Number of Patients Without Major Adverse Events Within 30 Days	30 days	Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
Number of Patients With Device Success	12 months	Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (37): Summa Akron
🇺🇸
Akron, Ohio, United States
Cooper University Hospital
🇺🇸
Camden, New Jersey, United States
Sentara Vascular Specialists
🇺🇸
Norfolk, Virginia, United States
SUNY at Stony Brook Hospital
🇺🇸
Stony Brook, New York, United States
Piedmont Hospital
🇺🇸
Atlanta, Georgia, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Hamilton General Hospital
🇨🇦
Hamilton, Ontario, Canada
Morton Plant Hospital
🇺🇸
Clearwater, Florida, United States
Borgess Research Institute
🇺🇸
Kalamazoo, Michigan, United States
New York University - Langone Medical Center
🇺🇸
New York, New York, United States
Aspirus Wausau
🇺🇸
Wausau, Wisconsin, United States
Baptist Health Louisville
🇺🇸
Louisville, Kentucky, United States
Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
University of Massachusetts Medical School
🇺🇸
Worcester, Massachusetts, United States
Gundersen Lutheran Medical Center
🇺🇸
La Crosse, Wisconsin, United States
Missouri Heart Center
🇺🇸
Columbia, Missouri, United States
SUNY Upstate
🇺🇸
Syracuse, New York, United States
Newark Beth Israel Medical Center
🇺🇸
Newark, New Jersey, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Bend Memorial Clinic
🇺🇸
Bend, Oregon, United States
Wm Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Charleston Area Medical Center
🇺🇸
Charleston, West Virginia, United States
Massachusetts General
🇺🇸
Boston, Massachusetts, United States
University of Washington-Harborview Medical Center
🇺🇸
Seattle, Washington, United States
Good Samaritan-Trihealth
🇺🇸
Cincinnati, Ohio, United States
Stanford University Medical Center
🇺🇸
Stanford, California, United States
University of Florida
🇺🇸
Gainesville, Florida, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Baptist Memorial Hospital-Memphis
🇺🇸
Memphis, Tennessee, United States
University of Colorado
🇺🇸
Aurora, Colorado, United States
Mayo Clinic Rochester
🇺🇸
Rochester, Minnesota, United States
Iowa Heart Center
🇺🇸
West Des Moines, Iowa, United States
St. John's Mercy Medical Center
🇺🇸
Saint Louis, Missouri, United States
St. Vincent's Heart and Vascular Center
🇺🇸
Billings, Montana, United States
University of Rochester
🇺🇸
Rochester, New York, United States
Wake Forest Baptist Medical Center
🇺🇸
Winston-Salem, North Carolina, United States