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
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