Stroke Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 18 or older
- People who were largely independent in daily life before the planned procedure (with little to no disability, as measured by a standard stroke scale) (confirm with trial site)
- People who have an unruptured or previously treated (but returned) brain aneurysm — or a previously ruptured aneurysm, as long as the rupture happened more than 30 days before the planned procedure
- People whose aneurysm has a specific shape (sac-like or tube-like), is located in or near a particular artery at the base of the brain (the internal carotid artery or its branches), has a wide opening (neck of 4mm or more, or a specific dome-to-neck ratio), and sits in a blood vessel of a certain size (confirm exact measurements with trial site)
- People, or their legally authorised representative, who have given written consent and agreed to follow all study procedures
Who may not be able to join:
- People who have previously had a flow diverter or stent placed in the blood vessel connected to the aneurysm being treated
- People who have another brain aneurysm that needs treatment within 3 months after the procedure
- People who have had a brain bleed (subarachnoid haemorrhage) in the 30 days before the planned procedure
- People whose aneurysm sits exactly at a point where a blood vessel splits into two branches (a true bifurcation aneurysm)
- People whose blood vessel anatomy makes the procedure unsafe due to severe twisting or narrowing, or who have had a stent placed in the nearby carotid artery within the past 3 months
- People who have a brain arteriovenous malformation (AVM) or other abnormal blood vessel condition near the target aneurysm
- People who have had major surgery or another endovascular procedure in the past 30 days, or have one planned within 90 days of joining the study
- People whose neurological condition has been worsening in the past 30 days
- People with a known serious allergic reaction to the dye used in medical imaging scans that cannot be managed with medication
- People with a known sensitivity or allergy to nickel, titanium, or their alloys, or to any component of the device being studied
- People with an irreversible bleeding disorder or signs of active bleeding at the time of assessment
- People with known kidney failure with certain abnormal blood test results, unless already on dialysis (confirm with trial site)
- People who cannot undergo CT scans, MRI, or angiography (a type of blood vessel imaging)
- People who cannot take blood-thinning or anti-clotting medications such as aspirin, heparin, clopidogrel, prasugrel, or ticagrelor, or who have known allergies to these
- People with a known blood clotting disorder, or certain abnormal blood test results on admission (confirm specific values with trial site)
- People with another serious life-threatening illness unrelated to the brain condition being treated (such as acute kidney or heart failure)
- People who are unable to attend the required follow-up appointments during the study
- People who show signs of active infection at the time of treatment (such as fever or elevated infection markers in blood tests)
- People who are already taking part in another clinical trial that could influence the results of this study
- People who are currently pregnant, breastfeeding, or planning to become pregnant during the study period
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Demetrius Lopes, MD, Advocate Aurora Research Institute, LLC
Phone: +353 91 740 100
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Primary Efficacy and Performance Endpoint: Number of subjects with 100% occlusion of the target aneurysm without significant parent artery stenosis and no retreatment of the target aneurysm from the index procedure to the 12-month follow-up visit.; The Primary Safety Endpoint: Number of subjects with ischemic or hemorrhagic stroke or neurologic death from treatment to 12-months, as adjudicated by a Clinical Events Committee.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.