Abdominal Aortic AneurysmNCT02440113
Post-operative CT Follow up After Nellix Endoprosthesis Implantation
An observational study of Abdominal Aortic Aneurysm and Endovascular Aortic Repair, run by Rijnstate Hospital.
Trial summary
Multicenter retrospective CT follow up after aortic aneurysm repair using Nellix Endoprosthesis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Aortic Aneurysm, Endovascular Aortic Repair, Nellix Endovascular Sealing
- What is being tested?
- Nellix
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Aug 2015
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent Nellix endovascular aortic repair
Who may be able to join
- Patients who underwent endovascular abdominal aneurysm repair using the Nellix endoprosthesis
Who cannot join
- No specific exclusion criteria
About this study
Official title: Post-operative CT Follow up Measurement After Nellix Endoprosthesis Implantation in Patients With Abdominal Aortic Aneurysms.
Multicenter retrospective CT follow up after aortic aneurysm repair using Nellix Endoprosthesis.
Read the detailed description
Rationale:
In patients with abdominal aortic aneurysms the Nellix Endoprosthesis aims to reduce post-operative complications and subsequent re-intervention rates. Using two stents covered with two polymer filled endobags used for sealing and excluding the aneurysm sac. Preliminary results show promising results in reducing these complications. The new endoprosthesis is not only different in treatment but also in follow up imaging. To date it is unknown how the stent, polymer filled endobags and aneurysm appear in CT imaging in short and long term follow up.
Objective:
To assess and describe the normal computed tomography (CT) appearance at 30 days and 1 year after implantation of the Nellix Endoprosthesis.
Study population:
Approximately a total of 100 patients who underwent endovascular aneurysm repair using Nellix endoprosthesis in three different hospitals. The population is comprised of approximately fifty patients from Rijnstate Ziekenhuis Arnhem and twenty-five each from St. Antonius Nieuwegein and St. Elisabeth Tilburg.
Design and methods:
The study is designed as a multicenter retrospective cohort. Using CT-scans from regular follow up dates (30 days and 1 year) imaging will be retrospectively assessed using medical imaging software. Main study endpoints are defined as followed:
- Changes in the infrarenal neck morphology (below the renal arteries)
- Changes in the thrombus in the aneurysm sac
- Changes in the aneurysm wall and geometry
- Changes in the cobalt-chromium stent and their lumen
- Changes in the polymer-filled endobags Using anonymous patient data a database will be created an securely stored. Patient consent for study participation will be attained before accessing patient files.
Nature and extent of the burden and risk associated with participation, benefit and group relatedness:
The study will not bring an extra burden or risk for patients participating. Patients are encouraged to participate to improve insight for patients with the same disease and might improve health care in the future for this group of patients.
- Being tested
- Nellix
- 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.
NellixDevice
Nellix Implantation
| Study group | Role | What they receive |
|---|---|---|
| Nellix | Patients with endovascular Nellix repair Receives: Device: Nellix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the infrarenal neck morphology (below the renal arteries)
Measured: 1 year
Changes in the thrombus in the aneurysm sac
Measured: 1 year
Changes in the aneurysm wall and geometry
Measured: 1 year
Changes in the cobalt-chromium stent and their lumen
Measured: 1 year
Changes in the polymer-filled endobags Using anonymous patient data a database will be created an securely stored. Patient consent for study participation will be attained before accessing patient files
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startDec 2014
- Primary completionAug 2015
- Study completionAug 2015
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.
- 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Reijnen, Rijnstate Hospital
- Investigators
- Michel Reijnen, MD, PhD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440113
- Sponsor's protocol ID
- WP-14-857
- Status last verified
- Jul 2016
- First submitted
- 12 Jan 2015
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative CT Follow up Measurement After Nellix Endoprosthesis Implantation in Patients With Abdominal Aortic Aneurysms.
- ClinicalTrials.gov ID
- NCT02440113
- Acronym / sponsor ID
- WP-14-857
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 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.
Multicenter retrospective CT follow up after aortic aneurysm repair using Nellix Endoprosthesis.
Detailed description
Rationale:
In patients with abdominal aortic aneurysms the Nellix Endoprosthesis aims to reduce post-operative complications and subsequent re-intervention rates. Using two stents covered with two polymer filled endobags used for sealing and excluding the aneurysm sac. Preliminary results show promising results in reducing these complications. The new endoprosthesis is not only different in treatment but also in follow up imaging. To date it is unknown how the stent, polymer filled endobags and aneurysm appear in CT imaging in short and long term follow up.
Objective:
To assess and describe the normal computed tomography (CT) appearance at 30 days and 1 year after implantation of the Nellix Endoprosthesis.
Study population:
Approximately a total of 100 patients who underwent endovascular aneurysm repair using Nellix endoprosthesis in three different hospitals. The population is comprised of approximately fifty patients from Rijnstate Ziekenhuis Arnhem and twenty-five each from St. Antonius Nieuwegein and St. Elisabeth Tilburg.
Design and methods:
The study is designed as a multicenter retrospective cohort. Using CT-scans from regular follow up dates (30 days and 1 year) imaging will be retrospectively assessed using medical imaging software. Main study endpoints are defined as followed:
- Changes in the infrarenal neck morphology (below the renal arteries)
- Changes in the thrombus in the aneurysm sac
- Changes in the aneurysm wall and geometry
- Changes in the cobalt-chromium stent and their lumen
- Changes in the polymer-filled endobags Using anonymous patient data a database will be created an securely stored. Patient consent for study participation will be attained before accessing patient files.
Nature and extent of the burden and risk associated with participation, benefit and group relatedness:
The study will not bring an extra burden or risk for patients participating. Patients are encouraged to participate to improve insight for patients with the same disease and might improve health care in the future for this group of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nellix | – | Device: NellixPatients with endovascular Nellix repair |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent Nellix endovascular aortic repair
Key inclusion criteria (1 listed)
- Patients who underwent endovascular abdominal aneurysm repair using the Nellix endoprosthesis
Key exclusion criteria (1 listed)
- No specific exclusion criteria
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 |
|---|---|---|
| NellixNellix Implantation | Device | Nellix |
Primary outcome
Changes in the infrarenal neck morphology (below the renal arteries)
Time frame: 1 year
Changes in the thrombus in the aneurysm sac
Time frame: 1 year
Changes in the aneurysm wall and geometry
Time frame: 1 year
Changes in the cobalt-chromium stent and their lumen
Time frame: 1 year
Changes in the polymer-filled endobags Using anonymous patient data a database will be created an securely stored. Patient consent for study participation will be attained before accessing patient files
Time frame: 1 year
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 15 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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 Reijnen, MD, PhD principal investigator
Rijnstate Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Endovascular Aortic Repair, run by Rijnstate Hospital.
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 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 the infrarenal neck morphology (below the renal arteries) (time frame: 1 year). The study lists 5 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 15 Jul 2016.