Abdominal Aortic AneurysmNCT02461524
Endurant Evo International 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 9 sites in 5 countries.
Trial summary
The purpose of this trial is to evaluate the safety and effectiveness of the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system for endovascular treatment of subjects with 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
- 69 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Jun 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 CT 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 (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 bilaterally 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 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 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
9 sites in 5 countries.
9 sites in 5 countries
Netherlands3 sites
Rijnstate - Locatie Arnhem
Arnhem
Catharina Ziekenhuis
Eindhoven
Erasmus University Medical Center
Rotterdam
Belgium2 sites
Universitair Ziekenhuis Gent
Ghent
UZ Leuven - Campus Gasthuisberg
Leuven
About this study
The purpose of this trial is to evaluate the safety and effectiveness of the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system for endovascular treatment of subjects with infrarenal abdominal aortic or aortoiliac aneurysms.
Read the detailed description
The Endurant Evo International Clinical Trial is a prospective, multi-center, premarket, non-randomized, single-arm 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 |
|---|---|---|
| Abdominal Aortic Aneurysm Endovascular repair | Other | Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria. 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.
Primary Safety Endpoint Assessed by the Number of Participants 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
Primary Effectiveness Endpoint Assessed by the Number of Subjects With Technical Success at the Index Procedure.
Technical success at the index procedure (as assessed intra-operatively up until closure of the access site), 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
Measured: Index procedure
Secondary outcomes (13)
Number of Subjects With All-Cause Mortality (ACM) at Each Follow up
All-cause-mortality within 30, 183, and 365 days and annually until 5 years.
Measured: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point
Aneurysm-related mortality within 30, 183, and 365 days, then annually until 5-Year post-implantation
Measured: within 30, 183, and 365 days, then annually until 5-Year post-implantation
Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point
Secondary procedures to correct Type I and III endoleaks within 183 and 365 day, then annually until 5-Year post-implantation
Measured: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point
Secondary endovascular procedures within 30, 183, and 365 days, then annually until 5-Year post-implantation.
Measured: within 30, 183, and 365 days, then annually until 5-Year post-implantation
Number of Subjects With Serious Adverse Events (SAE)
Serious adverse events within 30, 183, and 365 days, then annually until 5-Year post-implantation
Measured: within 30, 183, and 365 days, then annually until 5-Year post-implantation
The Number of Subjects With Aneurysm Rupture
Aneurysm rupture within 30, 183, and 365 days, then annually until 5-Year post-implantation
Measured: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
The Number of Subjects With Conversion to Ppen Surgery
Conversion to open surgery within 30, 183, and 365 days, then annually until 5-Year post-implantation
Measured: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
The Number of Subjects With Major Adverse Events (MAE)
Major adverse events within 183, and 365 days, then annually until 5-Year post-implantation
Measured: Within 183, and 365 days, then annually until 5-Year post-implantation
the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging)
Stent graft migration (as compared to 1-month imaging) through 12-month, 24-month, 36-month, 48-month and 60-month using worst case.
Measured: Through 12-month, 24-month, 36-month, 48-month and 60-month
Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging)
Aneurysm expansion > 5 mm (as compared to 1-month imaging) at 12-month, 24-month, 36-month, 48-month and 60-month
Measured: 12-month, 24-month, 36-month, 48-month and 60-month
Number of Subject With Endoleaks Based on Imaging Findings
Table will show a total number of subjects with endoleak at each follow up time point
Measured: 1- month, 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
Number of Subjects With Stent Graft Occlusion Based on Imaging Findings
Stent graft occlusion based on imaging findings through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
Measured: Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
Number of Subject With Device Deficiencies Based on Imaging Findings
Total number of subject with Any Device Deficiency through the follow up time points.
Measured: Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startJun 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hence Verhagen, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461524
- Sponsor's protocol ID
- 10173339DOC
- Status last verified
- Sep 2023
- First submitted
- 1 Jun 2015
- Last updated
- 1 Apr 2024
- 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 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endurant Evo International Clinical Trial
- ClinicalTrials.gov ID
- NCT02461524
- Acronym / sponsor ID
- 10173339DOC
- 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
- 69 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Posted 1 Apr 2024
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 trial is to evaluate the safety and effectiveness of the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system for endovascular treatment of subjects with infrarenal abdominal aortic or aortoiliac aneurysms.
Detailed description
The Endurant Evo International Clinical Trial is a prospective, multi-center, premarket, non-randomized, single-arm trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal Aortic Aneurysm Endovascular repair | Other | Device: Endurant Evo AAA Stent Graft System, Procedure: Endovascular aneurysm repair (EVAR)Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria. |
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 | Abdominal Aortic Aneurysm Endovascular repair |
| Endovascular aneurysm repair (EVAR) | Procedure or surgery | Abdominal Aortic Aneurysm Endovascular repair |
Primary outcome
Primary Safety Endpoint Assessed by the Number of Participants Experiencing a Major Adverse Event (MAE) Within 30-days Post-implantation.
Time frame: 30 days
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
Primary Effectiveness Endpoint Assessed by the Number of Subjects With Technical Success at the Index Procedure.
Time frame: Index procedure
Technical success at the index procedure (as assessed intra-operatively up until closure of the access site), 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
13 secondary outcomes
Number of Subjects With All-Cause Mortality (ACM) at Each Follow up
Time frame: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point
Time frame: within 30, 183, and 365 days, then annually until 5-Year post-implantation
Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point
Time frame: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point
Time frame: within 30, 183, and 365 days, then annually until 5-Year post-implantation
Number of Subjects With Serious Adverse Events (SAE)
Time frame: within 30, 183, and 365 days, then annually until 5-Year post-implantation
The Number of Subjects With Aneurysm Rupture
Time frame: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
The Number of Subjects With Conversion to Ppen Surgery
Time frame: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
The Number of Subjects With Major Adverse Events (MAE)
Time frame: Within 183, and 365 days, then annually until 5-Year post-implantation
the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging)
Time frame: Through 12-month, 24-month, 36-month, 48-month and 60-month
Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging)
Time frame: 12-month, 24-month, 36-month, 48-month and 60-month
Number of Subject With Endoleaks Based on Imaging Findings
Time frame: 1- month, 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
Number of Subjects With Stent Graft Occlusion Based on Imaging Findings
Time frame: Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
Number of Subject With Device Deficiencies Based on Imaging Findings
Time frame: Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- 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.
Hence Verhagen, MD, PhD principal investigator
Erasmus Medical Center
9 sites in 5 countries: 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 9 sites in 5 countries.
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 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands, Austria, Belgium, Denmark, Sweden. 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 1 Apr 2024). 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 Assessed by the Number of Participants 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 1 Apr 2024.