Aortic Aneurysm, AbdominalFIH-NZNCT02907762
Aorfix Intelliflex First in Human Study
An observational study of Aortic Aneurysm, Abdominal, run by Lombard Medical.
Trial summary
The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with IntelliFlex™, the latest generation of the Aorfix™ AAA Flexible Stent Graft Delivery System, for… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Endovascular aneurysm repair EVAR
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2021
- How long will I take part?
- 5 Years
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair. 2. Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.
Who may be able to join
- Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
- Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.
Who cannot join
- Do not comply with the indications for Aorfix™ in the IFU.
- Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care of the investigative site.
- Unwillingness or inability to provide informed consent to both the study and the EVAR procedure.
- Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft.
About this study
Official title: Aorfix™ Generation IV Delivery System "IntelliFlex™" Study
The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with IntelliFlex™, the latest generation of the Aorfix™ AAA Flexible Stent Graft Delivery System, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Endovascular aneurysm repair EVAR
- Keywords
- Endovascular, EVAR, Neck Angulation
- 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 aneurysm repair EVARDevice
Also called Aorfix Intelliflex
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Successful Implant Delivery (30d)
Successful implant delivery is also called Primary Technical Success, defined as successful introduction and deployment of the device in the absence of surgical conversion or mortality, Type I or III endoleaks, or graft limb obstruction.
The numbers of participants having Primary Technical Success on completion of the index procedure and Clinical Success 12 months after the procedure will be recorded.
Measured: 1 Month
Number of participants with Treatment Success (1year)
Treatment success, or Clinical Success, requires successful deployment of the endovascular device at the intended location without death as a result of aneurysm-related treatment, Type I or III endoleak, graft infection or thrombosis, aneurysm expansion (diameter >=5 mm, or volume >=5%), aneurysm rupture, or conversion to open repair.
The numbers of participants having Primary Technical Success on completion of the index procedure and Clinical Success 12 months after the procedure will be recorded.
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 posted20 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies 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
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Lombard Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Holden, MD, Principal investigator, University of Auckland, NZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907762
- Sponsor's protocol ID
- 2015-07
- Acronym
- FIH-NZ
- Status last verified
- Oct 2021
- First submitted
- 7 Sep 2016
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aorfix™ Generation IV Delivery System "IntelliFlex™" Study
- ClinicalTrials.gov ID
- NCT02907762
- Acronym / sponsor ID
- FIH-NZ / 2015-07
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- Endovascular, EVAR, Neck Angulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Lombard MedicalIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 20 Sep 2016 (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 First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with IntelliFlex™, the latest generation of the Aorfix™ AAA Flexible Stent Graft Delivery System, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair. 2. Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.
Key inclusion criteria (2 listed)
- Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
- Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.
Key exclusion criteria (4 listed)
- Do not comply with the indications for Aorfix™ in the IFU.
- Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care of the investigative site.
- Unwillingness or inability to provide informed consent to both the study and the EVAR procedure.
- Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft.
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 aneurysm repair EVARAlso: Aorfix Intelliflex | Device | – |
Primary outcome
Number of participants with Successful Implant Delivery (30d)
Time frame: 1 Month
Successful implant delivery is also called Primary Technical Success, defined as successful introduction and deployment of the device in the absence of surgical conversion or mortality, Type I or III endoleaks, or graft limb obstruction. The numbers of participants having Primary Technical Success on completion of the index procedure and Clinical Success 12 months after the procedure will be recorded.
Number of participants with Treatment Success (1year)
Time frame: 12 Months
Treatment success, or Clinical Success, requires successful deployment of the endovascular device at the intended location without death as a result of aneurysm-related treatment, Type I or III endoleak, graft infection or thrombosis, aneurysm expansion (diameter >=5 mm, or volume >=5%), aneurysm rupture, or conversion to open repair. The numbers of participants having Primary Technical Success on completion of the index procedure and Clinical Success 12 months after the procedure will be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 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.
Andrew Holden, MD principal investigator
University of Auckland, NZ
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, Abdominal, run by Lombard Medical.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Nov 2021. 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?
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?
Number of participants with Successful Implant Delivery (30d) (time frame: 1 Month). 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 1 Nov 2021.