Vascular AneurysmEASYNCT04765176
A PMCF Study in Patients With Infrarenal Aortic Aneurysm Treated With the E-tegra Stent Graft System
An observational study of Vascular Aneurysm, run by JOTEC GmbH at 1 site in Netherlands.
Trial summary
The EASY post-market clinical follow-up study is undertaken to demonstrate safety and clinical performance of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Aneurysm
- What is being tested?
- Endovascular Repair
- Type of treatment
- Medical device
- How many people
- 151 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2021to 1 Oct 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Male and female patients with asymptomatic infrarenal aortic aneurysm who are eligible for the endovascular treatment with the E-tegra Stent Graft System in accordance to the inclusion and exclusion criteria.
Who may be able to join
- Age ≥ 18
- Patient must have an infrarenal aortic aneurysm with diameter ≥ 50 mm in females and ≥ 55 mm in males, or infrarenal aortic aneurysm with 40-50 mm that has increased in size by ≥ 1 cm per year
- Patient is elegible for treatment inside the instructions for use of the E-tegra Stent Graft System
- Patient is able and willing to undergo follow-up imaging and examinations prior to discharge from the hospital, at 30 days and 12 months, and annually thereafter until 5 years follow-up
- Patient understands and has signed the Informed Consent Form prior to intervention
- Patient has a life expectancy of at least 5 years
Who cannot join
- Patient with severe calcification or thrombi in the proximal sealing zone
- Patient with infectious aneurysm
- Patient with inflammatory aneurysm
- Patient with pseudoaneurysm
- Patient with symptomatic aneurysm
- Patient with ruptured or traumatic aneurysm
Show all 18Show fewer
- Patient with suprarenal, juxtarenal, or pararenal aneurysm
- Patient with aortic dissection
- Patient with a reversed conical neck that is defined as a > 3 mm distal increase over a 15 mm length
- Patient in which the E-tegra Stent Graft System is used in combination with proximal or distal extenders of another company.
- Patient who is planned to be treated with an adjunctive aortic bare metal stent or a fenestrated stent graft
- Patient who is planned to be treated with a chimney / chimneys in the renal or visceral vessels
- Patient who is planned to be treated with an iliac branch device or parallel grafts in the iliac vessels
- Patient with genetic connective tissue disease (e.g. Marfan syndrome or Ehlers-Danlos syndrome)
- Patient with eGFR < 45 ml/min/1.73 m2 before the intervention
- Patient had or planned to have a major surgical or interventional procedure within 30 days before or 30 days after the planned implantation of the E-tegra Stent Graft System
- Patient with other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with a limited life expectancy of less than five years (i.e. heart failure, active malignancy (progressive, stable or partial remission))
- Patient who has been enrolled in another active clinical trial that does not allow inclusion in this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A European Post-Market Clinical Follow-up Study (PMCF) in Patients With Infrarenal Aortic Aneurysm Undergoing Endovascular Stenting With the E-tegra Stent Graft System
The EASY post-market clinical follow-up study is undertaken to demonstrate safety and clinical performance of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.
Read the detailed description
In this study, patients will be observed who receive an E-tegra Stent Graft for the treatment of infrarenal aortic aneurysm. The E-tegra Stent Graft will be implanted at the discretion of the treating physician.
Participating physicians will provide their observations collected during routine care for patients they have decided to treat with the E-tegra stent graft. Informed consent of the patients to the use of their clinical records for study purposes will be obtained before their data will be collected in the post-market clinical follow-up study. All patients will be asked to complete questionaires focussing on the health status (HS) (SF-12) and Quality of Life (QoL) (WHOQOL-BREF).
The period of data collection will be approximately 60 months from the date of intervention for each patient. Source document verification will be performed on 100% of the patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans as well as other imaging files (e.g. CEUS, MRT) will be sent to a CoreLab for independent second evaluation. There is no CoreLab screening before inclusion. All adverse events defined prior to study start, will be adjudicated by the Clinical Evaluation Committee (CEC).
- Conditions
- Vascular Aneurysm
- Being tested
- Endovascular Repair
- Keywords
- Abdominal, Aorta, Aneurysm, Endovascular, Repair
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular RepairDevice
Endovascular repair of the infrarenal aorta using a AAA stent graft.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Rate of all-cause mortality
Measured: 30-day
Secondary outcomes (25)
Mortality
Rate of all-cause mortality
Measured: 24 hours, 12, 24, 36, 60 months
Aneurysm-related mortality
Rate of aneurysm-related mortality
Measured: 30-day, 12, 24, 36, 60 months
Aneurysm rupture-related mortality
Rate of aneurysm rupture-related mortality
Measured: 30-day, 12, 24, 36, 60 months
Technical success
Rate of patients with device technical success
Measured: 24 hours
Clinical success
Rate of patients with clinical success
Measured: 12 months
Reintervention
Rate of patients with any reintervention
Measured: 30-day, 12, 24, 36, 60 months
Reintervention-free survival
Rate of patients with reintervention-free survival
Measured: 12 months
Primary limb patency
Rate of patients with primary E-tegra Stent Graft limb patency
Measured: 30-day, 12, 24, 36, 60 months
Secondary limb patency
Rate of patients with secondary E-tegra Stent Graft limb patency
Measured: 30-day, 12, 24, 36, 60 months
Stable aneurysm size
Rate of patients with stable aneurysm size
Measured: 12, 60 months
Decreasing aneurysm size
Rate of patients with decreasing aneurysm size on CTA scan (≤ 5 mm in maximum diameter)
Measured: 12, 60 months
Increasing aneurysm size
Rate of patients with aneurysm growth on CTA scan (≥ 5 mm in maximum diameter)
Measured: 12, 60 months
Major adverse events
Rate of patients with major adverse events (aneurysm-related death, aneurysm rupture, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), new disabling stroke (mRS ≥ 2), visceral ischemia (bowel ischemia with surgical/endovascular intervention or submission to ICU or bowel necrosis with surgical/endovascular intervention or submission to ICU), new hepatic infarction, new chronic (> 90 days) renal insufficiency/renal failure requiring dialysis, new permanent (> 30 days) paraplegia (modified Tarlov Scale ≤ 2), new permanent (> 30 days) paraparesis (modified Tarlov Scale 3 or 4), lower limb ischemia (increase in Rutherford classification)
Measured: 30-day, 12, 24, 36, 60 months
Endoleak Type Ia
Rate of patients with Type Ia endoleak
Measured: 12, 60 months
Endoleak Type Ib
Rate of patients with Type Ib endoleak
Measured: 12, 60 months
Endoleak Type II
Rate of patients with Type II endoleak
Measured: 12, 60 months
Endoleak Type III
Rate of patients with Type III endoleak
Measured: 12, 60 months
Endoleak Type IV
Rate of patients with Type IV endoleak
Measured: 12, 60 months
Endoleak of unknown origin
Rate of patients with endoleak of unknown origin
Measured: 12, 60 months
Stent graft migration
Rate of patients with stent graft migration > 10 mm
Measured: 12, 60 months
Dislodgement
Rate of patients with stent graft dislodgement (full component separation)
Measured: 30-day, 12, 24, 36, 60 months
Stent fracture
Rate of patients with stent fracture
Measured: 12, 60 months
Stent graft infection
Rate of patients with stent graft infection
Measured: 30-day, 12, 24, 36, 60 months
Health status
Rate of patients with the same level of health status as prior to surgery
Measured: 6, 12, 48 to 60 months
QoL
Rate of patients with the same level of QoL as prior to surgery
Measured: 6, 12, 48 to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2023
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AneurysmStudies of the same condition, open and under way.
- More trials run by JOTEC GmbHThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel MP Reijnen, Prof., Principal investigator, Rijnstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765176
- Sponsor's protocol ID
- EASY
- Acronym
- EASY
- Status last verified
- Jul 2024
- First submitted
- 18 Feb 2021
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A European Post-Market Clinical Follow-up Study (PMCF) in Patients With Infrarenal Aortic Aneurysm Undergoing Endovascular Stenting With the E-tegra Stent Graft System
- ClinicalTrials.gov ID
- NCT04765176
- Acronym / sponsor ID
- EASY / EASY
- Conditions
- Vascular Aneurysm
- Keywords
- Abdominal, Aorta, Aneurysm, Endovascular, Repair
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 151 participants (actual)
- Lead sponsor
- JOTEC GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The EASY post-market clinical follow-up study is undertaken to demonstrate safety and clinical performance of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.
Detailed description
In this study, patients will be observed who receive an E-tegra Stent Graft for the treatment of infrarenal aortic aneurysm. The E-tegra Stent Graft will be implanted at the discretion of the treating physician.
Participating physicians will provide their observations collected during routine care for patients they have decided to treat with the E-tegra stent graft. Informed consent of the patients to the use of their clinical records for study purposes will be obtained before their data will be collected in the post-market clinical follow-up study. All patients will be asked to complete questionaires focussing on the health status (HS) (SF-12) and Quality of Life (QoL) (WHOQOL-BREF).
The period of data collection will be approximately 60 months from the date of intervention for each patient. Source document verification will be performed on 100% of the patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans as well as other imaging files (e.g. CEUS, MRT) will be sent to a CoreLab for independent second evaluation. There is no CoreLab screening before inclusion. All adverse events defined prior to study start, will be adjudicated by the Clinical Evaluation Committee (CEC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients with asymptomatic infrarenal aortic aneurysm who are eligible for the endovascular treatment with the E-tegra Stent Graft System in accordance to the inclusion and exclusion criteria.
Key inclusion criteria (6 listed)
- Age ≥ 18
- Patient must have an infrarenal aortic aneurysm with diameter ≥ 50 mm in females and ≥ 55 mm in males, or infrarenal aortic aneurysm with 40-50 mm that has increased in size by ≥ 1 cm per year
- Patient is elegible for treatment inside the instructions for use of the E-tegra Stent Graft System
- Patient is able and willing to undergo follow-up imaging and examinations prior to discharge from the hospital, at 30 days and 12 months, and annually thereafter until 5 years follow-up
- Patient understands and has signed the Informed Consent Form prior to intervention
Key exclusion criteria (18 listed)
- Patient with severe calcification or thrombi in the proximal sealing zone
- Patient with infectious aneurysm
- Patient with inflammatory aneurysm
- Patient with pseudoaneurysm
- Patient with symptomatic aneurysm
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 |
|---|---|---|
| Endovascular RepairEndovascular repair of the infrarenal aorta using a AAA stent graft. | Device | – |
Primary outcome
Mortality
Time frame: 30-day
Rate of all-cause mortality
25 secondary outcomes
Mortality
Time frame: 24 hours, 12, 24, 36, 60 months
Aneurysm-related mortality
Time frame: 30-day, 12, 24, 36, 60 months
Aneurysm rupture-related mortality
Time frame: 30-day, 12, 24, 36, 60 months
Technical success
Time frame: 24 hours
Clinical success
Time frame: 12 months
Reintervention
Time frame: 30-day, 12, 24, 36, 60 months
Reintervention-free survival
Time frame: 12 months
Primary limb patency
Time frame: 30-day, 12, 24, 36, 60 months
Secondary limb patency
Time frame: 30-day, 12, 24, 36, 60 months
Stable aneurysm size
Time frame: 12, 60 months
Decreasing aneurysm size
Time frame: 12, 60 months
Increasing aneurysm size
Time frame: 12, 60 months
Major adverse events
Time frame: 30-day, 12, 24, 36, 60 months
Endoleak Type Ia
Time frame: 12, 60 months
Endoleak Type Ib
Time frame: 12, 60 months
Endoleak Type II
Time frame: 12, 60 months
Endoleak Type III
Time frame: 12, 60 months
Endoleak Type IV
Time frame: 12, 60 months
Endoleak of unknown origin
Time frame: 12, 60 months
Stent graft migration
Time frame: 12, 60 months
Dislodgement
Time frame: 30-day, 12, 24, 36, 60 months
Stent fracture
Time frame: 12, 60 months
Stent graft infection
Time frame: 30-day, 12, 24, 36, 60 months
Health status
Time frame: 6, 12, 48 to 60 months
QoL
Time frame: 6, 12, 48 to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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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 MP Reijnen, Prof. principal investigator
Rijnstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Aneurysm, run by JOTEC GmbH at 1 site in Netherlands.
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 6 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mortality (time frame: 30-day). 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 25 Jul 2024.