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

Not Applicable

Completed

Conditions: Abdominal Aortic Aneurysms

Interventions: Device: Endurant Stent Graft System

Registration Number: NCT00705718

Lead Sponsor: Medtronic Cardiovascular

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

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 194

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endurant Bifurcated arm	Endurant Stent Graft System	The Bifurcated arm includes subjects who have received a bifurcated device. The Endurant Stent Graft System Bifurcated device is administered to treat patients with an Abdominal Aortic Aneurysm.
Endurant AUI arm	Endurant Stent Graft System	The AUI arm includes subjects who have received an AUI device. The Endurant Stent Graft System AUI device is administered to treat patients with an Abdominal Aortic Aneurysm.

Primary Outcome Measures

Name	Time	Method
Major Adverse Events Within 30 Days of Index Procedure	30 days	The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events. * All-Cause Mortality * Bowel Ischemia * Myocardial Infarction * Paraplegia * Procedural Blood Loss \> or equal to 1000 cc * Renal Failure * Respiratory Failure * Stroke
Primary Effectiveness Endpoint (Treatment Success)	12 months	Treatment success is defined as Technical success and the following: * Freedom from AAA diameter increased, defined as \>5 mm increase in maximum diameter as measured on CT scan (or MRA/MRI) at 12 months as compared to 1 month * Freedom from Types I and III endoleaks at 12 months including those requiring intervention through 12 months * Freedom from aneurysm rupture through 12 months * Freedom from conversion to surgery through 12 months * Freedom from stent graft migrations resulting in a serious adverse event or requiring secondary intervention through 12 months * Freedom from stent graft occlusion at 12 months
Primary Effectiveness Endpoint (Technical Success)	Intra-operatively	Technical success defined as successful delivery and deployment of the stent graft in the planned location and with no unintentional coverage of both the internal iliac arteries or any visceral aortic branches and with removal of the system. Technical success was assessed intra-operatively.
Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)	30 days (Safety)	The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events. * All-Cause Mortality * Bowel Ischemia * Myocardial Infarction * Paraplegia * Procedural Blood Loss \> or equal to 1000 cc * Renal Failure * Respiratory Failure * Stroke

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints - Safety Evaluation	12 months	The following secondary endpoints were included in the Pivotal trial to evaluate the safety profile of the Endurant Stent Graft System. * Aneurysm-Related Mortality through 12 months * All-Cause Mortality with 30 days * All-Cause Mortality within 12 months * Major Adverse Events through 12 months * Adverse Events through 12 months * Unanticipated Adverse Device Events * Serious Adverse Events (SAEs) As reported at the time of the data cut off. * Device Related Adverse Events * Procedure Related Adverse Events * Adverse Events (excluding SAEs)
Secondary Endpoint - Effectiveness Evaluation	12 months	The following secondary endpoints were included in the pivotal trial to evaluate the effectiveness profile of the Endurant Stent Graft System. * Stent Graft migration through 12 months * Stent Graft Patency through 12 months * All stent Graft Endoleaks at 1-month, 6-months, and 12-month * Secondary Procedures to correct Type I and type III Endoleaks through 12 months * Secondary Endovascular Procedures through 12 months * Technical Observations through 12 months

Trial Locations

Locations (30): Albany Medical Center
🇺🇸
Albany, New York, United States
University of Pennsylvania Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Dartmouth Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Arizona Heart Institute
🇺🇸
Phoenix, Arizona, United States
Lindner Clinical Trial Center
🇺🇸
Cincinnati, Ohio, United States
Harborview Medical Center
🇺🇸
Seattle, Washington, United States
University of Alabama Hospitals
🇺🇸
Birmingham, Alabama, United States
Stanford University Medical Center
🇺🇸
Stanford, California, United States
Sarasota Memorial Hospital
🇺🇸
Sarasota, Florida, United States
Wellstar Kennestone Hospital
🇺🇸
Marietta, Georgia, United States
Good Samaritan Hospital
🇺🇸
Downers Grove, Illinois, United States
Iowa Methodist Medical Center
🇺🇸
Des Moines, Iowa, United States
St. John's Mercy Medical Center
🇺🇸
Saint Louis, Missouri, 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
Jobst Vascular Center
🇺🇸
Toledo, Ohio, 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