Solitaire FR Thrombectomy for Acute Revascularisation
Switzerland202 participantsStarted 2010-10
Plain-language summary
The objective of this study was to obtain prospective clinical data on the safety and efficacy of the Solitaire™ FR device for patients diagnosed with acute ischemic stroke.
Who can participate
Age range
18 Years – 84 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
. Subject or subject's legally authorized representative has signed and dated an Informed Consent Form
. Age ≥ 18 and \< 85
. Clinical signs consistent with acute ischemic stroke
. Thrombolysis in Cerebral Infarction (TICI) 0 or TICI 1 flow in the proximal anterior intracranial vasculature (M1 or M2 of Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) intracranial, Internal Carotid Artery (ICA) terminal)
. Presentation within 8 hours of stroke onset according to local stroke protocol
. If stroke presentation within 4.5 hours, one of these conditions can be met:
. Subject is willing to conduct follow-up visits.
. National Institutes of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30
Exclusion criteria
. Females who are pregnant or lactating
. Known serious sensitivity to radiographic contrast agents
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
1
Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device.
Timeframe: Immediately post procedure
2
Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs).
. Neurological signs that are rapidly improving prior to or at time of treatment
. Current participation in another investigational drug or device study
. Life expectancy of less than 90 days
. National Institutes of Health Stroke Scale (NIHSS) \> 30 or coma
. Uncontrolled hypertension defined as systolic blood pressure \> 185 or diastolic blood pressure \> 110 that cannot be controlled except with continuous parenteral antihypertensive medication
. Use of warfarin anticoagulation with International Normalised Ratio (INR) \> 3.0