Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System
This trial is active, not recruiting.
|Condition||abdominal aortic aneurysms|
|Treatment||endurant stent graft system|
|Start date||June 2008|
|End date||September 2012|
|Trial size||194 participants|
|Trial identifier||NCT00705718, Medtronic - 089|
To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
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|Birmingham, AL||University of Alabama Hospitals||no longer recruiting|
|Phoenix, AZ||Arizona Heart Institute||no longer recruiting|
|Stanford, CA||Stanford University Medical Center||no longer recruiting|
|Sarasota, FL||Sarasota Memorial Hospital||no longer recruiting|
|Atlanta, GA||Emory University Hospital||no longer recruiting|
|Marietta, GA||Wellstar Kennestone Hospital||no longer recruiting|
|Chicago, IL||Northwestern Memorial Hospital||no longer recruiting|
|Downers Grove, IL||Good Samaritan Hospital||no longer recruiting|
|Des Moines, IA||Iowa Methodist Medical Center||no longer recruiting|
|Boston, MA||Massachusetts General Hospital||no longer recruiting|
|St. Louis, MO||St. John's Mercy Medical Center||no longer recruiting|
|Lebanon, NH||Dartmouth Hitchcock Medical Center||no longer recruiting|
|Albany,, NY||Albany Medical Center||no longer recruiting|
|Buffalo, NY||Sisters of Charity Hospital||no longer recruiting|
|New York, NY||Mount Sinai School of Medicine||no longer recruiting|
|New York, NY||NYU Hospitals Center||no longer recruiting|
|Asheville, NC||Mission Hospitals||no longer recruiting|
|Charlotte, NC||Mid Carolina Presbyterian Hospital||no longer recruiting|
|Cincinnati, OH||Lindner Clinical Trial Center||no longer recruiting|
|Cleveland, OH||Cleveland Clinic||no longer recruiting|
|Toledo, OH||Jobst Vascular Center||no longer recruiting|
|Philadelphia, PA||University of Pennsylvania Hospital||no longer recruiting|
|Pittsburgh, PA||Allegheny General Hospital||no longer recruiting|
|Pittsburgh, PA||University of Pittsburgh Medical Center||no longer recruiting|
|Sioux Falls, SD||Sanford Research||no longer recruiting|
|Memphis, TN||Baptist Memorial Hospital Memphis||no longer recruiting|
|Powell, TN||Premier Surgical Associates||no longer recruiting|
|Dallas, TX||UT Southwestern Medical Center||no longer recruiting|
|Temple, TX||Scott & White Memorial Medical Center||no longer recruiting|
|Seattle, WA||Harborview Medical Center||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)
time frame: 30 days (Safety)
Major Adverse Events Within 30 Days of Index Procedure
time frame: 30 days
Primary Effectiveness Endpoint (Technical Success)
time frame: Intra-operatively
Primary Effectiveness Endpoint (Treatment Success)
time frame: 12 months
Secondary Endpoints - Safety Evaluation
time frame: 12 months
Secondary Endpoint - Effectiveness Evaluation
time frame: 12 months
Male or female participants at least 18 years old.
- 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.
- 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.
|Official title||Endurant Stent Graft System US Clinical Study|
|Principal investigator||Michel S Makaroun, MD|
|Description||Prospective, two-arm, non-randomized, multicenter clinical study enrolling subjects treated with the bifurcated stent graft in one arm and subjects treated with the AUI in a second arm.|
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