Intracranial AneurysmACCESSNCT01194388
Axium Coil in Completing Endovascular Aneurysm Surgery Study
An observational study of Intracranial Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 1 site in United States.
Trial summary
The current observational evaluation is designed to evaluate the performance of the Axium™ MicroFx™ Detachable Coil System for the treatment of intracranial aneurysms in the real life practice. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- MicroFx™ PGLA COILS
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Feb 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
Official title: Axium Coil in Completing Endovascular Aneurysm Surgery Study: A Single-center, Prospective Observational Registry
The current observational evaluation is designed to evaluate the performance of the Axium™ MicroFx™ Detachable Coil System for the treatment of intracranial aneurysms in the real life practice.
Read the detailed description
Up to 25 patients from from US centers are anticipated to be enrolled for this evaluation. Published literature on coils with electrolytic, thermal or hydraulic detachment will serve as the basis for control comparisons to the Axium™ MicroFx™ Detachable Coil System for patients undergoing embolization of intracranial aneurysm. Comparison will be based on criteria evaluating the safety of the procedure, the reliability of detachment, the occlusion stability and the packing density impact.
- Conditions
- Intracranial Aneurysm
- Being tested
- MicroFx™ PGLA COILS
- Keywords
- Patients presenting with an intracranial aneurysm
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroFx™ PGLA COILSDevice
. This observational evaluation will evaluate early experience using the Axium™ MicroFx™ Detachable 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.
| Study group | Role | What they receive |
|---|---|---|
| MicroFx™ PGLA Treated Subjects | Not described Receives: Device: MicroFx™ PGLA COILS |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194388
- Sponsor's protocol ID
- ACCESS-09012010
- Acronym
- ACCESS
- Status last verified
- May 2021
- First submitted
- 1 Sep 2010
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axium Coil in Completing Endovascular Aneurysm Surgery Study: A Single-center, Prospective Observational Registry
- ClinicalTrials.gov ID
- NCT01194388
- Acronym / sponsor ID
- ACCESS / ACCESS-09012010
- Conditions
- Intracranial Aneurysm
- Keywords
- Patients presenting with an intracranial aneurysm
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 3 Sep 2010 (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 current observational evaluation is designed to evaluate the performance of the Axium™ MicroFx™ Detachable Coil System for the treatment of intracranial aneurysms in the real life practice.
Detailed description
Up to 25 patients from from US centers are anticipated to be enrolled for this evaluation. Published literature on coils with electrolytic, thermal or hydraulic detachment will serve as the basis for control comparisons to the Axium™ MicroFx™ Detachable Coil System for patients undergoing embolization of intracranial aneurysm. Comparison will be based on criteria evaluating the safety of the procedure, the reliability of detachment, the occlusion stability and the packing density impact.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MicroFx™ PGLA Treated Subjects | – | Device: MicroFx™ PGLA COILS |
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 |
|---|---|---|
| MicroFx™ PGLA COILS. This observational evaluation will evaluate early experience using the Axium™ MicroFx™ Detachable 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. | Device | MicroFx™ PGLA Treated Subjects |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 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.
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 Intracranial 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: withdrawn, as of the sponsor's last update on 26 May 2021. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 26 May 2021.