Abdominal Aortic AneurysmSECURENCT02485496
E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms
An observational study of Abdominal Aortic Aneurysm and AAA, run by JOTEC GmbH at 10 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate clinical and technical success as well as safety and feasibility 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
- Abdominal Aortic Aneurysm, AAA
- What is being tested?
- Endovascular abdominal repair
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 10 sitesin 5 countries
- Study dates
- Jun 2015to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 infrarenal aortic or aorto-iliac aneurysm who are eligible for treatment with an abdominal stent graft according to the instructions for use for the E-tegra stent graft system, and scheduled for implantation of the E-tegra stent graft system at their physician's discretion in accordance with the inclusion and exclusion criteria.
Who may be able to join
- Patients must comply with the indications for use
- Patient must have an infrarenal aortic aneurysm with diameter >5cm or an infrarenal aortic aneurysm with 4 to 5cm that has increased in size by 0.5cm in the last 6 months
- Patient must be available for the appropriate follow-up times for the duration of the study
- Patient has signed the informed consent before intervention
Who cannot join
- Patients with one of the contraindications as indicated in the instructions for use
- Patients with infectious aneurysm
- Patients with inflammatory aneurysm
- Patients with pseudoaneurysm
- Patients with ruptured or traumatic aneurysm
- Patients with suprarenal, juxtarenal, or pararenal aneurysm
Show all 15Show fewer
- Patients with aortic dissection
- Patients with a reversed conical neck that is defined as a >3mm distal increase over a 15mm length
- Patients who have a congenital degenerative Collagen disease or connective tissue disorder
- Patients with thrombocytopenia
- Patients with creatinine >2.4 mg/dl immediately before the Intervention
- Patients with hyperthyreosis
- Patients with malignancy needing chemotherapy or Radiation
- Patients who are enrolled in another clinical study
- Patients with life expectancy of less than 24 months
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Poland3 sites
Szpital Uniwersytecki im. dr. Antoniego Jurasza
Bydgoszcz, 85-094
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, 20-081
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, 02-097
Germany2 sites
Klinikum Chemnitz
Chemnitz, 09116
Universitätsklinikum Leipzig
Leipzig, 04103
Spain2 sites
Hospital Joan XXIII
Tarragona
Hospital Clinico Universitario Valladolid
Valladolid, 47005
About this study
Official title: SECURE - A poSt-market Registry in Patients With infrarEnal aortiC Aneurysm Undergoing endovasculaR Stenting With the New E-tegra Stent Graft System
The purpose of this study is to evaluate clinical and technical success as well as safety and feasibility of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.
- Conditions
- Abdominal Aortic Aneurysm, AAA
- Being tested
- Endovascular abdominal repair
- 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.
Endovascular abdominal repairDevice
Also called EVAR
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of aneurysm rupture and aneurysm related death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2020
- Study completionDec 2021
Why it stopped: Due to product change.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sven Seifert, Dr., Principal investigator, Klinikum Chemnitz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485496
- Sponsor's protocol ID
- SECURE
- Acronym
- SECURE
- Status last verified
- May 2022
- First submitted
- 26 Jun 2015
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SECURE - A poSt-market Registry in Patients With infrarEnal aortiC Aneurysm Undergoing endovasculaR Stenting With the New E-tegra Stent Graft System
- ClinicalTrials.gov ID
- NCT02485496
- Acronym / sponsor ID
- SECURE / SECURE
- Conditions
- Abdominal Aortic Aneurysm, AAA
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to product change.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- JOTEC GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jul 2020 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 30 Jun 2015 (estimated)
- 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 purpose of this study is to evaluate clinical and technical success as well as safety and feasibility of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 infrarenal aortic or aorto-iliac aneurysm who are eligible for treatment with an abdominal stent graft according to the instructions for use for the E-tegra stent graft system, and scheduled for implantation of the E-tegra stent graft system at their physician's discretion in accordance with the inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- Patients must comply with the indications for use
- Patient must have an infrarenal aortic aneurysm with diameter >5cm or an infrarenal aortic aneurysm with 4 to 5cm that has increased in size by 0.5cm in the last 6 months
- Patient must be available for the appropriate follow-up times for the duration of the study
- Patient has signed the informed consent before intervention
Key exclusion criteria (15 listed)
- Patients with one of the contraindications as indicated in the instructions for use
- Patients with infectious aneurysm
- Patients with inflammatory aneurysm
- Patients with pseudoaneurysm
- Patients with ruptured or traumatic 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 abdominal repairAlso: EVAR | Device | – |
Primary outcome
Rate of aneurysm rupture and aneurysm related death
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Due to product change.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
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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.
Sven Seifert, Dr. principal investigator
Klinikum Chemnitz
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and AAA, run by JOTEC GmbH at 10 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 4 inclusion and 15 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Poland, France, Germany, Spain, Switzerland. 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?
The study was stopped early (reason given: Due to product change.). Results are not available in the source record.
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?
Rate of aneurysm rupture and aneurysm related death (time frame: 2 years). 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 May 2022.