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

Primary Purpose

Abdominal Aortic Aneurysms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endurant Stent Graft System
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysms focused on measuring Endurant Stent Graft System, Abdominal Aortic Aneurysms, Endovascular Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama Hospitals
  • Arizona Heart Institute
  • Stanford University Medical Center
  • Sarasota Memorial Hospital
  • Emory University Hospital
  • Wellstar Kennestone Hospital
  • Northwestern Memorial Hospital
  • Good Samaritan Hospital
  • Iowa Methodist Medical Center
  • Massachusetts General Hospital
  • St. John's Mercy Medical Center
  • Dartmouth Hitchcock Medical Center
  • Albany Medical Center
  • Sisters of Charity Hospital
  • NYU Hospitals Center
  • Mount Sinai School of Medicine
  • Mission Hospitals
  • Mid Carolina Presbyterian Hospital
  • Lindner Clinical Trial Center
  • Cleveland Clinic
  • Jobst Vascular Center
  • University of Pennsylvania Hospital
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center
  • Sanford Research
  • Baptist Memorial Hospital Memphis
  • Premier Surgical Associates
  • UT Southwestern Medical Center
  • Scott & White Memorial Medical Center
  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Endurant Bifurcated arm

Endurant AUI arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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.
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

Secondary Outcome Measures

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)
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

Full Information

First Posted
June 24, 2008
Last Updated
October 27, 2021
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT00705718
Brief Title
Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System
Official Title
Endurant Stent Graft System US Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 2008 (Actual)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysms
Keywords
Endurant Stent Graft System, Abdominal Aortic Aneurysms, Endovascular Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endurant Bifurcated arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Endurant AUI arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Endurant Stent Graft System
Other Intervention Name(s)
Endovascular treatment of Abdominal Aortic Aneurysm
Intervention Description
Abdominal Aortic Aneurysm Repair
Primary Outcome Measure Information:
Title
Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)
Description
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
Time Frame
30 days (Safety)
Title
Major Adverse Events Within 30 Days of Index Procedure
Description
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
Time Frame
30 days
Title
Primary Effectiveness Endpoint (Technical Success)
Description
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.
Time Frame
Intra-operatively
Title
Primary Effectiveness Endpoint (Treatment Success)
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Secondary Endpoints - Safety Evaluation
Description
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)
Time Frame
12 months
Title
Secondary Endpoint - Effectiveness Evaluation
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel S Makaroun, MD
Organizational Affiliation
Division of Vascular Surgery University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Hospitals
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Heart Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Good Samaritan Hospital
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
St. John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Sisters of Charity Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Facility Name
NYU Hospitals Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mission Hospitals
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Mid Carolina Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Jobst Vascular Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Sanford Research
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Baptist Memorial Hospital Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Premier Surgical Associates
City
Powell
State/Province
Tennessee
ZIP/Postal Code
37849
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Scott & White Memorial Medical Center
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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