AneurysmAMERICANCT01323439
Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study
An observational study of Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 1 site in United States.
Trial summary
This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aneurysm
- What is being tested?
- Axium™ MicroFX™ PGLA COILS
- Type of treatment
- Medical device
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Oct 2012
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting with an intracranial aneurysm will be evaluated by the neuro interventional team, in accordance with institutional practice, to establish an appropriate treatment plan based on the patient's medical condition and available diagnostic screening prior to recruitment
Who may be able to join
- Confirmed diagnosis of one or more intracranial aneurysm, either ruptured or unruptured.
- Information on data collection provided to the patient or legally authorized representative and signed informed consent.
- Aneurysm diameter ≤10mm .
- Age range of 18 - 90.
Who cannot join
- Aneurysm previously treated.
- Aneurysm AVM related or dissecting.
- Participation in a clinical investigation of other aneurysm treating or related devices.
- Any condition that would preclude the conduct of protocol follow-up.
- Aneurysm anatomy that is determined inappropriate for Axium coil placement, prior to opening of an Axium coil.
Trial locations and contacts
1 site in 1 country.
About this study
This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms.
Read the detailed description
This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 99 patients at 13 study centers. The primary endpoint of the trial was the anatomic occlusion of the aneurysm in the immediate post-procedure angiogram basedon the Raymond classification. Secondary endpoints included safety during the procedure, safety after the procedure, detachment system performance, stability of the embolization, and packing efficacy.
- Conditions
- Aneurysm
- Being tested
- Axium™ MicroFX™ PGLA COILS
- Keywords
- Patients presenting with an intracranial aneurysm
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axium™ MicroFX™ PGLA COILSDevice
Axium™ MicroFX™ PGLA COILS to treat aneurysms
| Study group | Role | What they receive |
|---|---|---|
| Axium™ MicroFX™ PGLA Treated Subjects | This observational evaluation will evaluate early experience using the Axium™ MicroFX™ PGLA COILS as compared to published literature of coils with electrolytic, thermal or hydraulic detachment process or the Axium™ Bare Detachable Coils arm obtained from previous evaluation conducted following the same protocol Receives: Device: Axium™ MicroFX™ PGLA COILS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic occlusion of the aneurysm
Occlusion of aneurysm based on the Raymond classification
Measured: Immediately post-procedure
Secondary outcomes (5)
Safety during the procedure
Morbidity and mortality rate
Measured: Discharge, up to two years
Safety post-procedure
Morbidity and mortality rate
Measured: 3-6 months follow-up
Detachment system performance
Occurrence of detachment failure
Measured: During procedure
Stability of embolization
Rate of change towards worsening Raymond grades
Measured: 3-6 months follow-up
Packing efficacy
increase in packing density calculated as ration between volume of coils and the aneurysm volume
Measured: 36- months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startApr 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Florida
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323439
- Sponsor's protocol ID
- AMERICA
- Acronym
- AMERICA
- Status last verified
- Aug 2017
- First submitted
- 23 Mar 2011
- Last updated
- 30 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study
- ClinicalTrials.gov ID
- NCT01323439
- Acronym / sponsor ID
- AMERICA / AMERICA
- Conditions
- Aneurysm
- Keywords
- Patients presenting with an intracranial aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Collaborators
- University of Florida
- Study start
- Apr 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 25 Mar 2011 (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.
This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms.
Detailed description
This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 99 patients at 13 study centers. The primary endpoint of the trial was the anatomic occlusion of the aneurysm in the immediate post-procedure angiogram basedon the Raymond classification. Secondary endpoints included safety during the procedure, safety after the procedure, detachment system performance, stability of the embolization, and packing efficacy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axium™ MicroFX™ PGLA Treated Subjects | – | Device: Axium™ MicroFX™ PGLA COILSThis observational evaluation will evaluate early experience using the Axium™ MicroFX™ PGLA COILS as compared to published literature of coils with electrolytic, thermal or hydraulic detachment process or the Axium™ Bare Detachable Coils arm obtained from previous evaluation conducted following the same protocol |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting with an intracranial aneurysm will be evaluated by the neuro interventional team, in accordance with institutional practice, to establish an appropriate treatment plan based on the patient's medical condition and available diagnostic screening prior to recruitment
Key inclusion criteria (4 listed)
- Confirmed diagnosis of one or more intracranial aneurysm, either ruptured or unruptured.
- Information on data collection provided to the patient or legally authorized representative and signed informed consent.
- Aneurysm diameter ≤10mm .
- Age range of 18 - 90.
Key exclusion criteria (5 listed)
- Aneurysm previously treated.
- Aneurysm AVM related or dissecting.
- Participation in a clinical investigation of other aneurysm treating or related devices.
- Any condition that would preclude the conduct of protocol follow-up.
- Aneurysm anatomy that is determined inappropriate for Axium coil placement, prior to opening of an Axium coil.
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 |
|---|---|---|
| Axium™ MicroFX™ PGLA COILSAxium™ MicroFX™ PGLA COILS to treat aneurysms | Device | Axium™ MicroFX™ PGLA Treated Subjects |
Primary outcome
Anatomic occlusion of the aneurysm
Time frame: Immediately post-procedure
Occlusion of aneurysm based on the Raymond classification
5 secondary outcomes
Safety during the procedure
Time frame: Discharge, up to two years
Safety post-procedure
Time frame: 3-6 months follow-up
Detachment system performance
Time frame: During procedure
Stability of embolization
Time frame: 3-6 months follow-up
Packing efficacy
Time frame: 36- months follow-up
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 30 Aug 2017.
- Individual participant dataSharing planned: No
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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 Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 1 site in United States.
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 5 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 30 Aug 2017. 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 United States. 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?
Anatomic occlusion of the aneurysm (time frame: Immediately post-procedure). 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 30 Aug 2017.