Aortic AneurysmNCT02438605
Dynamic CT Imaging After Nellix Endoprosthesis Implantation
An observational study of Aortic Aneurysm, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
The Nellix Endovascular Sealing Prosthesis (EVAS) endoprosthesis is a new device aimed at prophylactic treatment of abdominal aortic aneurysms. In regular follow up conventional CT-imaging is used for surveillance. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- Nellix
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2015to Feb 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients eligible for endovascular aortic repair using the Nellix endovascular sealing system
Who may be able to join
- Nellix implantation
Who cannot join
- Use of chimneys or combined with other stent graft material
Trial locations and contacts
1 site in 1 country.
About this study
The Nellix Endovascular Sealing Prosthesis (EVAS) endoprosthesis is a new device aimed at prophylactic treatment of abdominal aortic aneurysms. In regular follow up conventional CT-imaging is used for surveillance. In this study dynamic CT imaging in patients pre- and post-operative will be assessed for device changes and anatomical variances.
- Conditions
- Aortic Aneurysm
- Being tested
- Nellix
- Keywords
- Nellix, EVAS, EVAR, Dynamic CT, Dyna CT
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NellixDevice
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Patients eligible for AAA repair using Nellix and willing to participate in this trial. Receives: Device: Nellix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in aortic aneurysm morphology as seen on dynamic CT after EVAS
Measured: 1 month
Secondary outcomes (2)
Dynamic changes in neck morphology after EVAS
Measured: 1 month
Dynamic changes in common iliac artery morphology after EVAS.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Reijnen, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438605
- Sponsor's protocol ID
- StM 596
- Status last verified
- Jun 2016
- First submitted
- 6 May 2015
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic CT Imaging After Nellix Endoprosthesis Implantation
- ClinicalTrials.gov ID
- NCT02438605
- Acronym / sponsor ID
- StM 596
- Conditions
- Aortic Aneurysm
- Keywords
- Nellix, EVAS, EVAR, Dynamic CT, Dyna CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 May 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 Nellix Endovascular Sealing Prosthesis (EVAS) endoprosthesis is a new device aimed at prophylactic treatment of abdominal aortic aneurysms. In regular follow up conventional CT-imaging is used for surveillance. In this study dynamic CT imaging in patients pre- and post-operative will be assessed for device changes and anatomical variances.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Device: NellixPatients eligible for AAA repair using Nellix and willing to participate in this trial. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients eligible for endovascular aortic repair using the Nellix endovascular sealing system
Key inclusion criteria (1 listed)
- Nellix implantation
Key exclusion criteria (1 listed)
- Use of chimneys or combined with other stent graft material
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 |
|---|---|---|
| Nellix | Device | Treatment group |
Primary outcome
Changes in aortic aneurysm morphology as seen on dynamic CT after EVAS
Time frame: 1 month
2 secondary outcomes
Dynamic changes in neck morphology after EVAS
Time frame: 1 month
Dynamic changes in common iliac artery morphology after EVAS.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aortic Aneurysm, run by Rijnstate Hospital 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 1 inclusion and 1 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 1 Jul 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in aortic aneurysm morphology as seen on dynamic CT after EVAS (time frame: 1 month). 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 Jul 2016.