Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System

Completed · Not applicable

Conditions studied: Abdominal Aortic Aneurysms

In brief

To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.

Key facts

Study ID: NCT00705718
Run by: Medtronic Cardiovascular
People needed: 194
Starts: 2008-06-01
Expected to finish: 2016-09-26
Last updated by the study team: 2021-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is ≥ 18 years old.
Subject (or Subject's legal representative) understands and voluntarily has signed and dated an Informed Consent document approved by the Sponsor and by the Institutional Review Board.
Subject is able and willing to comply with the protocol and undergo follow-up requirements.
Subject is a suitable candidate for elective surgical repair of AAA by as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, III, or IV
Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter
Subject meets all the protocol anatomical criteria* as demonstrated on contrast-enhanced CT or MRA
Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft
Subject has documented imaging evidence of at least 1 patent iliac and 1 femoral artery, or can tolerate a vascular conduit that allows introduction of the device.
Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System.

You may not qualify if…

Subject has a life expectancy < 1 year
Subject is participating in another investigational drug or device study
Subject requires emergent aneurysm treatment
Subject is a female of childbearing potential in whom pregnancy cannot be excluded.
Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.

Where it is running

Good Samaritan Hospital — Downers Grove, Illinois, United States
Iowa Methodist Medical Center — Des Moines, Iowa, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
St. John's Mercy Medical Center — St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
Albany Medical Center — Albany, New York, United States
Sisters of Charity Hospital — Buffalo, New York, United States
NYU Hospitals Center — New York, New York, United States
Mount Sinai School of Medicine — New York, New York, United States
Mission Hospitals — Asheville, North Carolina, United States
Mid Carolina Presbyterian Hospital — Charlotte, North Carolina, United States
Lindner Clinical Trial Center — Cincinnati, Ohio, United States
Cleveland Clinic — Cleveland, Ohio, United States
Jobst Vascular Center — Toledo, Ohio, United States
University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Sanford Research — Sioux Falls, South Dakota, United States
Baptist Memorial Hospital Memphis — Memphis, Tennessee, United States
Premier Surgical Associates — Powell, Tennessee, United States
UT Southwestern Medical Center — Dallas, Texas, United States
Scott & White Memorial Medical Center — Temple, Texas, United States
Harborview Medical Center — Seattle, Washington, United States
University of Alabama Hospitals — Birmingham, Alabama, United States
Arizona Heart Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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