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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endurant Stent Graft System US Clinical Study
- ClinicalTrials.gov ID
- NCT00705718
- Acronym / sponsor ID
- Medtronic - 089
- Conditions
- Abdominal Aortic Aneurysms
- Keywords
- Endurant Stent Graft System, Abdominal Aortic Aneurysms, Endovascular Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Jun 2008 (actual)
- Primary completion
- Sep 2012 (actual)
- Study completion
- 26 Sep 2016 (actual)
- First posted
- 26 Jun 2008 (estimated)
- Results
- Posted 21 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endurant Bifurcated arm | Experimental | Device: Endurant Stent Graft SystemThe 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 | Experimental | Device: Endurant Stent Graft SystemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurant Stent Graft SystemAlso: Endovascular treatment of Abdominal Aortic AneurysmAbdominal Aortic Aneurysm Repair | Device | Endurant AUI arm, Endurant Bifurcated arm |
Primary outcome
Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)
Time frame: 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
Major Adverse Events Within 30 Days of Index Procedure
Time frame: 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 (Technical Success)
Time frame: 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 Effectiveness Endpoint (Treatment Success)
Time frame: 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
2 secondary outcomes
Secondary Endpoints - Safety Evaluation
Time frame: 12 months
Secondary Endpoint - Effectiveness Evaluation
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel S Makaroun, MD principal investigator
Division of Vascular Surgery University of Pittsburgh Medical Center
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurant Stent Graft System in people with Abdominal Aortic Aneurysms, run by Medtronic Cardiovascular at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure) (time frame: 30 days (Safety)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.