Intracranial Saccular Aneurysm, Either Rupture or UnrupturedNCT04905303
Solitaire Aneurysm Remodeling Registry
An observational study of Intracranial Saccular Aneurysm, Either Rupture or Unruptured and Wide Neck Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 1 site in France.
Trial summary
The objective of the registry is to evaluate the effectiveness and performance of the Solitaire Neurovascular Remodeling Device when used with embolic coils in the treatment of intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Saccular Aneurysm, Either Rupture or Unruptured, Wide Neck Aneurysm
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Jun 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed diagnosis of intracranial saccular aneurysm which can be treated with coil embolization and neurovascular stenting.
Who may be able to join
- Confirmed diagnosis of intracranial saccular aneurysms, either ruptured or unruptured
- Aneurysm requires current treatment with coils and a stent or aneurysm hs been previously treated with coils, but no prior placement of a stent.
- Aneurysm has a wide neck defined as having a neck equal to or greater than 4mm or a dome-to-neck ratio of <2.
- Patient is 18 years or older.
- Patient has a Hunt \& Hess score of III or less.
Who cannot join
- Patient has a fusiform or dissecting aneurysm type.
- Patient is contraindicated for either heparin or anti-platelet therapy.
- Patient has severe allergy to IV contrast medium.
- Patient has a known hypersensitivity to nickel-titanium.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Multi-center, Single-arm Registry to Evaluate the Efficacy of the Solitaire AB Neurovascular Remodeling Device in the Treatment of Wide-neck Intracranial Aneurysms
The objective of the registry is to evaluate the effectiveness and performance of the Solitaire Neurovascular Remodeling Device when used with embolic coils in the treatment of intracranial aneurysms.
- Keywords
- Intracranial aneurysms, Wide neck aneurysms
- Medical subject headings
- Intracranial Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Stable Stent placement with complete coverage across the aneurysm neck with parent artery patency
Measured: Six months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study startFeb 2009
- Primary completionFeb 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Saccular Aneurysm, Either Rupture or UnrupturedStudies 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
- Case only
- 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
- NCT04905303
- Sponsor's protocol ID
- SOLARE
- Status last verified
- May 2021
- First submitted
- 24 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-center, Single-arm Registry to Evaluate the Efficacy of the Solitaire AB Neurovascular Remodeling Device in the Treatment of Wide-neck Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT04905303
- Acronym / sponsor ID
- SOLARE
- Keywords
- Intracranial aneurysms, Wide neck aneurysms
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 27 May 2021 (actual)
- 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 objective of the registry is to evaluate the effectiveness and performance of the Solitaire Neurovascular Remodeling Device when used with embolic coils in the treatment of intracranial aneurysms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed diagnosis of intracranial saccular aneurysm which can be treated with coil embolization and neurovascular stenting.
Key inclusion criteria (5 listed)
- Confirmed diagnosis of intracranial saccular aneurysms, either ruptured or unruptured
- Aneurysm requires current treatment with coils and a stent or aneurysm hs been previously treated with coils, but no prior placement of a stent.
- Aneurysm has a wide neck defined as having a neck equal to or greater than 4mm or a dome-to-neck ratio of <2.
- Patient is 18 years or older.
- Patient has a Hunt \& Hess score of III or less.
Key exclusion criteria (4 listed)
- Patient has a fusiform or dissecting aneurysm type.
- Patient is contraindicated for either heparin or anti-platelet therapy.
- Patient has severe allergy to IV contrast medium.
- Patient has a known hypersensitivity to nickel-titanium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stable Stent placement with complete coverage across the aneurysm neck with parent artery patency
Time frame: Six months post-implant
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 27 May 2021.
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 Saccular Aneurysm, Either Rupture or Unruptured and Wide Neck Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 1 site in France.
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 5 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: withdrawn, as of the sponsor's last update on 27 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 France. 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.
What does the primary outcome measure?
Stable Stent placement with complete coverage across the aneurysm neck with parent artery patency (time frame: Six months post-implant). 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 27 May 2021.