Abdominal Aortic AneurysmsNCT02048514
The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms
A study testing The Nellix® EndoVascular Aneurysm Sealing System in people with Abdominal Aortic Aneurysms, run by Endologix at 4 sites in 4 countries.
Trial summary
The purpose of this clinical study is to evaluate the safety and device performance of the Nellix® EndoVascular Aneurysm Sealing System (Nellix System) for the treatment of infrarenal abdominal aortic aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms
- What is being tested?
- The Nellix® EndoVascular Aneurysm Sealing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Dec 2008to Dec 2017
- Phase
- Interventional
- 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
Who may be able to join
- At least 18 years of age
- Informed consent form understood and signed and patient agrees to all follow-up visits
- Is able and willing to comply with clinical follow-up requirements for one year
- Is able and willing to undergo Contrast-Enhanced Spiral CT scans
- Is a candidate for endovascular repair of an infrarenal aortic aneurysm with or without an iliac aneurysm with at least one of the following;
- aneurysm ≥ 4.5 cm in diameter, or
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- aneurysm is twice the diameter of the normal infrarenal aorta, or
- aneurysm is growing at a rate of ≥ 10 % per year
- Non-aneurysmal aortic neck length ≥ 5mm below the most inferior renal artery
- Proximal aortic neck diameter between 16 and 36mm
- Aortic neck angulation to the sac ≤ 60
- Common iliac artery diameter 8 to 35mm bilaterally
- Aneurysm blood lumen diameter ≤ 60mm
- Iliac and femoral arteries suitable for endovascular access with the Nellix System
Who cannot join
- Life expectancy ≤ 1 year
- Dissecting, ruptured, or leaking aneurysm (blood outside the aorta), has sustained recent trauma, is symptomatic, or is non-degenerative
- Aneurysm is thoraco-abdominal, suprarenal and/or mycotic
- Thoracic aneurysm ≥ 4.5cm in diameter
- AAA requires treatment that would result in bilateral occlusion of the internal iliac arteries
- Presence of mural thrombus > 50% circumferentially in aortic neck
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- Iliac aneurysm blood lumen diameter > 35mm
- Active infection, vasculitis, or systemic connective tissue disease (e.g., Rheumatoid arthritis, scleroderma, Marfan's syndrome, Ehlers-Danlos disease) at time of procedure
- History of prior treatment of abdominal aortic or iliac artery aneurysm disease
- Femoral or iliac artery occlusive disease such that device delivery is not possible
- Vascular access for delivery of device requires placement of vascular conduit or is through an established vascular graft
- Receiving dialysis
- History of hypercoagulability
- Allergy to IV contrast
- Serum creatinine level >2.0 mg/dL (or equivalent)
- Patient is pregnant or nursing
- Patient is currently enrolled in an investigational drug or device trial
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
The purpose of this clinical study is to evaluate the safety and device performance of the Nellix® EndoVascular Aneurysm Sealing System (Nellix System) for the treatment of infrarenal abdominal aortic aneurysms.
Read the detailed description
This is a multicenter, multi-country prospective, single-arm, non-randomized clinical trial. The comparative control arm is a combination of patient data drawn from the abdominal aortic aneurysms (AAA) open surgical control arms of four commercially approved AAA devices as part of the Society of Vascular Surgeons. Patients enrolled in this study will be pre-screened and have a diagnosis of an infrarenal AAA with or without the need for treatment of iliac artery aneurysm, are candidates for endovascular repair, and meet the eligibility criteria. Patients enrolled in the study will participate in follow-up visits 31 days, 6 months and at 1 year following the index procedure. At the follow-up visits there will be a clinical assessment, blood collection, and abdominal CT imaging of the patient.
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- The Nellix® EndoVascular Aneurysm Sealing System
- Keywords
- Aortic Aneurysm, Abdominal, Endovascular Procedures
- 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.
The Nellix® EndoVascular Aneurysm Sealing SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Nellix Aneurysm Sealing | Experimental | The Nellix® EndoVascular Aneurysm Sealing System Receives: Device: The Nellix® EndoVascular Aneurysm Sealing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety- Number of Major Adverse Events
The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) through 30 days after the index procedure.
Measured: 30 day
Device Performance
The primary performance endpoint is technical success defined as successful delivery and deployment of the device and freedom from open surgical conversion at 30 days.
Measured: 30 days
Secondary outcomes (1)
All Cause Mortality
Any death occurring during the study period, regardless of cause
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startDec 2008
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmsStudies 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
- 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
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048514
- Sponsor's protocol ID
- N09-01
- Status last verified
- Mar 2021
- First submitted
- 27 Jan 2014
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT02048514
- Acronym / sponsor ID
- N09-01
- Conditions
- Abdominal Aortic Aneurysms
- Keywords
- Aortic Aneurysm, Abdominal, Endovascular Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Jan 2014 (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 clinical study is to evaluate the safety and device performance of the Nellix® EndoVascular Aneurysm Sealing System (Nellix System) for the treatment of infrarenal abdominal aortic aneurysms.
Detailed description
This is a multicenter, multi-country prospective, single-arm, non-randomized clinical trial. The comparative control arm is a combination of patient data drawn from the abdominal aortic aneurysms (AAA) open surgical control arms of four commercially approved AAA devices as part of the Society of Vascular Surgeons. Patients enrolled in this study will be pre-screened and have a diagnosis of an infrarenal AAA with or without the need for treatment of iliac artery aneurysm, are candidates for endovascular repair, and meet the eligibility criteria. Patients enrolled in the study will participate in follow-up visits 31 days, 6 months and at 1 year following the index procedure. At the follow-up visits there will be a clinical assessment, blood collection, and abdominal CT imaging of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nellix Aneurysm Sealing | Experimental | Device: The Nellix® EndoVascular Aneurysm Sealing SystemThe Nellix® EndoVascular Aneurysm Sealing System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- At least 18 years of age
- Informed consent form understood and signed and patient agrees to all follow-up visits
- Is able and willing to comply with clinical follow-up requirements for one year
- Is able and willing to undergo Contrast-Enhanced Spiral CT scans
- Is a candidate for endovascular repair of an infrarenal aortic aneurysm with or without an iliac aneurysm with at least one of the following;
Key exclusion criteria (17 listed)
- Life expectancy ≤ 1 year
- Dissecting, ruptured, or leaking aneurysm (blood outside the aorta), has sustained recent trauma, is symptomatic, or is non-degenerative
- Aneurysm is thoraco-abdominal, suprarenal and/or mycotic
- Thoracic aneurysm ≥ 4.5cm in diameter
- AAA requires treatment that would result in bilateral occlusion of the internal iliac arteries
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 |
|---|---|---|
| The Nellix® EndoVascular Aneurysm Sealing System | Device | Nellix Aneurysm Sealing |
Primary outcome
Safety- Number of Major Adverse Events
Time frame: 30 day
The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) through 30 days after the index procedure.
Device Performance
Time frame: 30 days
The primary performance endpoint is technical success defined as successful delivery and deployment of the device and freedom from open surgical conversion at 30 days.
1 secondary outcome
All Cause Mortality
Time frame: 12 months
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 9 Mar 2021.
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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.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Nellix® EndoVascular Aneurysm Sealing System in people with Abdominal Aortic Aneurysms, run by Endologix at 4 sites in 4 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 17 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 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Colombia, Latvia, New Zealand, Venezuela. 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?
Safety- Number of Major Adverse Events (time frame: 30 day). 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 9 Mar 2021.