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

Endurant Stent Graft System US Clinical Study

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

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysms
• Intervention / Treatment: Device: Endurant Stent Graft System

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.

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama Hospitals
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Arizona Heart Institute
  • California
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Florida
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Marietta, Georgia, United States, 30106
      • Wellstar Kennestone Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Downers Grove, Illinois, United States, 60515
      • Good Samaritan Hospital
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Iowa Methodist Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • St. John's Mercy Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Buffalo, New York, United States, 14214
      • Sisters of Charity Hospital
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10016
      • NYU Hospitals Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospitals
    • Charlotte, North Carolina, United States, 28204
      • Mid Carolina Presbyterian Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Lindner Clinical Trial Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Toledo, Ohio, United States, 43606
      • Jobst Vascular Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Research
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital Memphis
    • Powell, Tennessee, United States, 37849
      • Premier Surgical Associates
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is ≥ 18 years old.
2. 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.
3. Subject is able and willing to comply with the protocol and undergo follow-up requirements.
4. 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
5. Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter
6. Subject meets all the protocol anatomical criteria* as demonstrated on contrast-enhanced CT or MRA
7. Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft
8. 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.
9. Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System.

Exclusion Criteria:

1. Subject has a life expectancy < 1 year
2. Subject is participating in another investigational drug or device study
3. Subject requires emergent aneurysm treatment
4. Subject is a female of childbearing potential in whom pregnancy cannot be excluded.
5. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
6. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endurant Bifurcated arm; 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.	Device: Endurant Stent Graft System; Abdominal Aortic Aneurysm Repair; Other Names: Endovascular treatment of Abdominal Aortic Aneurysm
Experimental: Endurant AUI arm; 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.	Device: Endurant Stent Graft System; Abdominal Aortic Aneurysm Repair; Other Names: Endovascular treatment of Abdominal Aortic Aneurysm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)	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	30 days (Safety)
Major Adverse Events Within 30 Days of Index Procedure	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	30 days
Primary Effectiveness Endpoint (Technical Success)	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.	Intra-operatively
Primary Effectiveness Endpoint (Treatment Success)	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoints - Safety Evaluation	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)	12 months
Secondary Endpoint - Effectiveness Evaluation	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	12 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: Michel S Makaroun, MD, Division of Vascular Surgery University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2008
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 26, 2016

Study Registration Dates

• First Submitted: June 24, 2008
• First Submitted That Met QC Criteria: June 25, 2008
• First Posted (Estimate): June 26, 2008

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Endurant Stent Graft System; Abdominal Aortic Aneurysms; Endovascular Treatment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: Medtronic - 089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No