Abdominal Aortic AneurysmNCT02393716
Endurant Evo US Clinical Trial
A study testing Endurant Evo AAA Stent Graft System and Endovascular aneurysm repair (EVAR) in people with Abdominal Aortic Aneurysm and AAA, run by Medtronic Cardiovascular at 14 sites in United States.
Trial summary
The purpose of this study is to demonstrate that the Endurant Evo Abdominal Aortic Aneurysm (AAA) stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, AAA
- What is being tested?
- Endurant Evo AAA Stent Graft System and Endovascular aneurysm repair (EVAR)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 14 sitesUnited States
- Study dates
- Apr 2015to 25 Jun 2021
- 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 understands and voluntarily has signed and dated the Informed Consent approved by the Sponsor and by the Ethics Committee/Institutional Review Board
- Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
- Subject is a suitable candidate for elective surgical repair of AAA as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, or III
- Subject has an infrarenal abdominal aortic or aortoiliac aneurysm characterized by one or more of the following:
- Aneurysm is >5 cm in diameter (diameter measured is perpendicular to the line of flow)
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- Aneurysm is 4 - 5 cm in diameter and has increased in size ≥0.5 cm within the previous 6 months
- Subject meets all the following anatomical criteria as demonstrated on contrast-enhanced computed tomography (CTA) or magnetic resonance angiography (MRA) imaging:
- Proximal neck length of ≥ 10 mm with ≤ 60° infrarenal and ≤ 45° suprarenal neck angulation or Proximal neck length of ≥ 15 mm with ≤ 75° infrarenal and ≤ 60° suprarenal neck angulation
- Subject has vascular dimensions, e.g., aortic and iliac diameters, lengths from renal arteries to iliac bifurcation and hypogastric arteries, in the range of sizes available for the Endurant Evo AAA stent graft system (measured intima to intima) and within the sizing recommendations (refer to Endurant Evo AAA stent graft system Instructions for Use (IFU))
- Subject has a proximal aortic neck diameter ≥ 18 mm and ≤ 32 mm
- The distal fixation center of the iliac arteries must have a diameter ≥ 7 mm and ≤ 25 mm bilaterally for the bifurcation and unilaterally for the Aorto-uni-iliac stent graft (AUI)
- Subject has documented imaging evidence of at least one patent iliac and one femoral artery, or can tolerate a vascular conduit that allows introduction of the Endurant Evo AAA stent graft system
- Subject has distal non-aneurysmal iliac (cylindrical) fixation length ≥20 mm bilateral for the bifurcation and unilaterally for the AUI
Who cannot join
- Subject has a life expectancy ≤1 year
- Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study
- Subject is pregnant
- Subject has an aneurysm that is:
- Suprarenal/pararenal/juxtarenal
- Isolated ilio-femoral
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- Mycotic
- Inflammatory
- Pseudoaneurysm
- Dissecting
- Ruptured
- Leaking but not ruptured
- Subject requires emergent aneurysm treatment
- Subject has a known, untreated thoracic aneurysm >4.5 cm in diameter at the time of screening
- Subject has been previously treated for an abdominal aortic aneurysm
- Subject has a history of bleeding diathesis or coagulopathy
- Subject has had or plans to have an unrelated major surgical or interventional procedure within 1 month before or after implantation of the Endurant Evo AAA stent graft
- Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to implantation of the Endurant Evo AAA stent graft
- Subject has a conical neck defined as a >4 mm distal increase from the lowest renal artery over a 10 mm length
- Subject has a known allergy or intolerance to the device materials
- Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment
- Subject has significant aortic thrombus and/or calcification at either the proximal or distal attachment centers that would compromise fixation and seal of the device at the discretion of the investigator
- Subject has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow
- Subject whose arterial access site is not anticipated to accommodate the diameter of the Endurant Evo AAA stent graft delivery system (13F-17F) due to vessel size, calcification, or tortuosity
- Subject is morbidly obese or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta at the discretion of the investigator
- Subject has active infection at the time of the index procedure documented by e.g. pain, fever, drainage, positive culture and/or leukocytosis considered to be clinically significant per investigator discretion
- Subject has congenital degenerative collagen disease, e.g., Marfan's Syndrome
- Subject has a creatinine level > 2.00 mg/dl (or >176.8 μmol/L)
- Subject is on dialysis
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Michigan Health Sysem
Ann Arbor, Michigan, 48109
Heart Hospital of Austin
Austin, Texas, 78756-4080
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215-5324
University of Virginia
Charlottesville, Virginia, 22908
Erlanger Medical Center
Chattanooga, Tennessee, 37403-2147
The Christ Hospital
Cincinnati, Ohio, 45219-2906
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, 17101-2010
Aurora St. Lukes Medial Center
Milwaukee, Wisconsin, 53215-3669
Long Island Jewish Northshore University Hospital
New Hyde Park, New York, 11040
Maine Medical Center
Portland, Maine, 04102-3134
Kaiser Permanente Zion Medical Center
San Diego, California, 92123
Providence Sacred Heart Medical Center
Spokane, Washington, 99204-2307
Stanford Hospital & Clinics
Stanford, California, 94305-5330
Medstar Heart & Vascular Institute
Washington D.C., District of Columbia, 20010-3017
About this study
The purpose of this study is to demonstrate that the Endurant Evo Abdominal Aortic Aneurysm (AAA) stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.
Read the detailed description
The clinical evidence collected as part of this trial will be used in conjunction with data collected during the concurrently enrolling Endurant Evo International Clinical Trial.
- Conditions
- Abdominal Aortic Aneurysm, AAA
- Being tested
- Endurant Evo AAA Stent Graft System, Endovascular aneurysm repair (EVAR)
- 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 Evo AAA Stent Graft SystemDevice
Endovascular aneurysm repair (EVAR)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Endovascular repair | Other | Endurant Evo AAA Stent Graft System Receives: Device: Endurant Evo AAA Stent Graft System; Procedure: Endovascular aneurysm repair (EVAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation.
The percentage of subjects experiencing a Major Adverse Event (MAE) within 30 days post-implantation.
MAEs include the occurrence of any of the following events:
- All-cause mortality
- Bowel ischemia
- Myocardial infarction
- Paraplegia
- Procedural blood loss ≥1000 cc
- Renal failure
- Respiratory failure
- Stroke
Measured: 30-days
The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation.
Successful aneurysm treatment was achieved based on the following criteria:
Technical success at the index procedure (as assessed intra-operatively), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system AND
Treatment success consisting of freedom from:
- AAA diameter increase, defined as > 5 mm increase in maximum diameter as measured on computed tomography (CT) scan or magnetic resonance angiography/magnetic resonance imaging (MRA/MRI) at 12-month follow-up as compared to 1-month imaging
- Types I and III endoleaks at 12-month follow-up including those requiring intervention through 12 months
- Aneurysm rupture within 365 days
- Conversion to surgery within 365 days
- Stent graft migration resulting in a serious adverse event or requiring seco
Measured: 12-months
Secondary outcomes (13)
All-cause Mortality
All-cause mortality (ACM) within 30, 183, 365 days
Measured: within 30, 183, and 365 days
Aneurysm-related Mortality (ARM)
Aneurysm-related mortality (ARM) within 30, 183, and 365 days
Measured: within 30, 183, and 365 days
Secondary Procedures to Correct Type I and III Endoleaks
Any reintervention procedure (surgical or endovascular) following the completion of the operative initial implantation procedure that is used to correct a Type I and III endoleaks within 183 and 365 days. Type I endoleak was defined as a leak resulting from an incomplete seal of the endograft proximally or distally and a Type III endoleak was defined as a leak resulting from a defect of fabric or between the segments of the modular graft (junctional endoleak.
Measured: within 183, and 365 days
Secondary Procedures
Secondary procedures within 183 and 365 days
Measured: within 183, and 365 days
Serious Adverse Events
Serious adverse events within 30, 183 and 365 days.
Measured: within 30, 183, and 365 days
Conversion to Open Surgery
Conversion to open surgery within 183, and 365 days
Measured: within 183, and 365 days
Aneurysm Rupture
Aneurysm rupture within 183 and 365 days
Measured: within 183 and 365 days
Major Adverse Events
Major adverse events within 183 and 365 days
Measured: within 183 and 365 days
Stent Graft Migration
Stent graft movement of either the main body or iliac limb distally or proximally at 6- and 12-month follow-up visits (as compared to 1-month imaging). Main body stent graft migration is defined as evidence of movement of the main body stent graft relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature. Migration is observed when the stent graft completely covers a renal artery or movement is > 10 mm either distally or proximally. Stent graft limb/extension migration is defined as evidence of a movement of the stent graft limbs/extensions relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature that is > 10 mm or coverage of the internal iliac artery.
Measured: At 6- and 12-month follow-up visits (as compared to 1-month imaging)
Aneurysm Expansion >5 mm
Aneurysm expansion >5 mm at 6- and 12-month follow-up visits (as compared to 1-month imaging)
Measured: at 6- and 12-month follow-up visits (as compared to 1-month imaging)
All Endoleaks Based on Imaging Findings
All endoleaks based on imaging findings at 1-month, 6-month and 12-month. An endoleak is defined by the presence of contrast-enhanced blood outside the lumen of the endoluminal graft but within the aneurysm sac as seen on computed tomography (CT), angiography, ultrasound, or other appropriate imaging modality.
Measured: at 1-, 6-, and 12-month follow-up visits
Stent Graft Occlusions Based on Imaging Findings
Stent graft occlusions based on imaging findings through 1-, 6- and 12 months. Stent graft occlusion is defined as a 100% blockage of the lumen diameter of any implanted stent graft component(s) as evidenced by CT, angiography, ultrasound, or other appropriate imaging modality, and/or operative or pathological analysis.
Measured: Through 1-, 6- and 12 months
Device Deficiencies Based on Imaging Findings
Device deficiencies based on imaging findings through 6- and 12 months. A device deficiency was defined according Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance (ref. ISO 14155:2011 3.15).
Measured: Through 6- and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startApr 2015
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
Why it stopped: This study terminated enrollment due to device failures prior to enrollment completion.
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 AneurysmStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilbert Upchurch, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393716
- Sponsor's protocol ID
- 10173341DOC
- Status last verified
- Nov 2022
- First submitted
- 6 Mar 2015
- Last updated
- 6 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endurant Evo US Clinical Trial
- ClinicalTrials.gov ID
- NCT02393716
- Acronym / sponsor ID
- 10173341DOC
- Conditions
- Abdominal Aortic Aneurysm, AAA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study terminated enrollment due to device failures prior to enrollment completion.
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Posted 6 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that the Endurant Evo Abdominal Aortic Aneurysm (AAA) stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.
Detailed description
The clinical evidence collected as part of this trial will be used in conjunction with data collected during the concurrently enrolling Endurant Evo International Clinical Trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular repair | Other | Device: Endurant Evo AAA Stent Graft System, Procedure: Endovascular aneurysm repair (EVAR)Endurant Evo AAA Stent Graft System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject is ≥18 years old
- Subject understands and voluntarily has signed and dated the Informed Consent approved by the Sponsor and by the Ethics Committee/Institutional Review Board
- Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
- Subject is a suitable candidate for elective surgical repair of AAA as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, or III
- Subject has an infrarenal abdominal aortic or aortoiliac aneurysm characterized by one or more of the following:
Key exclusion criteria (29 listed)
- Subject has a life expectancy ≤1 year
- Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study
- Subject is pregnant
- Subject has an aneurysm that is:
- Subject requires emergent aneurysm 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 Evo AAA Stent Graft System | Device | Endovascular repair |
| Endovascular aneurysm repair (EVAR) | Procedure or surgery | Endovascular repair |
Primary outcome
The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation.
Time frame: 30-days
The percentage of subjects experiencing a Major Adverse Event (MAE) within 30 days post-implantation. MAEs include the occurrence of any of the following events: * All-cause mortality * Bowel ischemia * Myocardial infarction * Paraplegia * Procedural blood loss ≥1000 cc * Renal failure * Respiratory failure * Stroke
The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation.
Time frame: 12-months
Successful aneurysm treatment was achieved based on the following criteria: Technical success at the index procedure (as assessed intra-operatively), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system AND Treatment success consisting of freedom from: * AAA diameter increase, defined as > 5 mm increase in maximum diameter as measured on computed tomography (CT) scan or magnetic resonance angiography/magnetic resonance imaging (MRA/MRI) at 12-month follow-up as compared to 1-month imaging * Types I and III endoleaks at 12-month follow-up including those requiring intervention through 12 months * Aneurysm rupture within 365 days * Conversion to surgery within 365 days * Stent graft migration resulting in a serious adverse event or requiring seco
13 secondary outcomes
All-cause Mortality
Time frame: within 30, 183, and 365 days
Aneurysm-related Mortality (ARM)
Time frame: within 30, 183, and 365 days
Secondary Procedures to Correct Type I and III Endoleaks
Time frame: within 183, and 365 days
Secondary Procedures
Time frame: within 183, and 365 days
Serious Adverse Events
Time frame: within 30, 183, and 365 days
Conversion to Open Surgery
Time frame: within 183, and 365 days
Aneurysm Rupture
Time frame: within 183 and 365 days
Major Adverse Events
Time frame: within 183 and 365 days
Stent Graft Migration
Time frame: At 6- and 12-month follow-up visits (as compared to 1-month imaging)
Aneurysm Expansion >5 mm
Time frame: at 6- and 12-month follow-up visits (as compared to 1-month imaging)
All Endoleaks Based on Imaging Findings
Time frame: at 1-, 6-, and 12-month follow-up visits
Stent Graft Occlusions Based on Imaging Findings
Time frame: Through 1-, 6- and 12 months
Device Deficiencies Based on Imaging Findings
Time frame: Through 6- and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- 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.
Gilbert Upchurch, MD principal investigator
University of Florida
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurant Evo AAA Stent Graft System and Endovascular aneurysm repair (EVAR) in people with Abdominal Aortic Aneurysm and AAA, run by Medtronic Cardiovascular at 14 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 14 inclusion and 29 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: stopped early, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 6 Dec 2022). 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?
The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation. (time frame: 30-days). The study lists 2 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 6 Dec 2022.