French eCLIPs™ Efficacy and Safety Investigation (NCT05330897) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
French eCLIPs™ Efficacy and Safety Investigation
France119 participantsStarted 2021-12-16
Plain-language summary
The objective of this study is to demonstrate the safety and efficacy of the eCLIPs™ products for the treatment of bifurcation 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
. Patient whose age is greater than 18 years old
. Patient with an unruptured or previously ruptured (at least 1 month from date of rupture and with partial occlusion of the dome of the aneurysm by endovascular techniques or by open neurosurgery, and in stable neurological condition-WFNS I and II with a good recovery to at least to mRS 0-2) saccular, intracranial aneurysm or recurrent aneurysm, which arises at a bifurcation of Basilar Tip or Carotid Terminus with a minimal diameter of 5mm and a maximal diameter \<25mm, has a neck length of \>4mm or dome:neck ratio \<2, branch artery diameters in the range of 2.0mm to 3.25mm
. Patient aneurysm arises at a bifurcation artery with at least one of the two branch artery vessels having a diameter between 2.0mm and 3.25mm
. Patient understands the nature of the procedure and has the capacity to provide informed consent (including fluency in French language)
. Patient is willing to have on-site 30- day, 6-month, and 12 month follow-up evaluations as per standard clinical practice
Exclusion criteria
. Patient with an aneurysm deemed to be an eligible candidate for surgical clipping by the investigator
. Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region
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
Complete aneurysm occlusion with no recurrence or re-treatment
Timeframe: 12 months
2
Major stroke or non-accidental death within 30 days, or major ipsilateral stroke or neurological death between 31 days and 12 months
. Major surgery within previous 30 days or planned in the next 120 days after enrolment
. Patient with an International Normalized Ratio (INR) ≥ 1.5
. Patient with serum creatinine level ≥104 µmol/L (or 2.5mg/dL) at time of enrolment
. Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction at time of enrolment
. Patient who has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation
. Patient with any condition that, in the opinion of the treating physician, would place the participant at a high risk of embolic stroke or with any medical co-morbidity likely to affect the outcome (e.g. pulmonary disease, uncontrolled diabetes, blood disorders)