WithdrawnNot Applicable

Solitaire Aneurysm Remodeling Registry

France0Started 2009-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stable Stent placement with complete coverage across the aneurysm neck with parent artery patency

Timeframe: Six months post-implant

Trial details

NCT IDNCT04905303

SponsorMedtronic Neurovascular Clinical Affairs

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2011-02

View on ClinicalTrials.gov More Intracranial Saccular Aneurysm, Either Rupture or Unruptured trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.