Abdominal Aortic AneurysmsNCT00705718
Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System
A study testing Endurant Stent Graft System in people with Abdominal Aortic Aneurysms, run by Medtronic Cardiovascular at 30 sites in United States.
Trial summary
To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms
- What is being tested?
- Endurant Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 30 sitesUnited States
- Study dates
- Jun 2008to 26 Sep 2016
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Albany Medical Center
Albany, New York, 12208
Mission Hospitals
Asheville, North Carolina, 28801
Emory University Hospital
Atlanta, Georgia, 30322
University of Alabama Hospitals
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Sisters of Charity Hospital
Buffalo, New York, 14214
Mid Carolina Presbyterian Hospital
Charlotte, North Carolina, 28204
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
UT Southwestern Medical Center
Dallas, Texas, 75390
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Good Samaritan Hospital
Downers Grove, Illinois, 60515
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Wellstar Kennestone Hospital
Marietta, Georgia, 30106
Baptist Memorial Hospital Memphis
Memphis, Tennessee, 38120
NYU Hospitals Center
New York, New York, 10016
Mount Sinai School of Medicine
New York, New York, 10029
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Arizona Heart Institute
Phoenix, Arizona, 85006
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Premier Surgical Associates
Powell, Tennessee, 37849
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Harborview Medical Center
Seattle, Washington, 98104
Sanford Research
Sioux Falls, South Dakota, 57104
St. John's Mercy Medical Center
St Louis, Missouri, 63141
Stanford University Medical Center
Stanford, California, 94305
Scott & White Memorial Medical Center
Temple, Texas, 76508
Jobst Vascular Center
Toledo, Ohio, 43606
About this study
Official title: 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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- Endurant Stent Graft System
- Keywords
- Endurant Stent Graft System, Abdominal Aortic Aneurysms, Endovascular Treatment
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurant Stent Graft SystemDevice
Also called Endovascular treatment of Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm Repair
| Study group | Role | What they receive |
|---|---|---|
| Endurant Bifurcated arm | Experimental | 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. Receives: Device: Endurant Stent Graft System |
| Endurant AUI arm | Experimental | 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. Receives: Device: Endurant Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 12 months
Secondary outcomes (2)
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)
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2012
- Study completion26 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abdominal Aortic AneurysmsStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel S Makaroun, MD, Principal investigator, Division of Vascular Surgery University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705718
- Sponsor's protocol ID
- Medtronic - 089
- Status last verified
- Oct 2021
- First submitted
- 24 Jun 2008
- Last updated
- 3 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No