Canadian eCLIPs™ Safety and Feasibility Study Protocol (NCT01957683) | Clinical Trial Compass
WithdrawnPhase 1
Canadian eCLIPs™ Safety and Feasibility Study Protocol
Stopped: insufficient funds
Canada0Started 2020-01
Plain-language summary
The purpose of this study is to evaluate the safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured intracranial bifurcation aneurysms in conjunction with embolization coils.
Who can participate
Age range
18 Years – 80 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 between 18 and 80 years old
. Patient with an unruptured, saccular, intracranial aneurysm or recurrent aneurysm, which arises at a bifurcation and has a neck length of ≤ 6mm and aneurysm size of 5-35mm
. 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.
. Patient is willing to have on-site 30- day, and 6-month, follow-up evaluations as per standard clinical practice.
Exclusion criteria
. Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
. Patient with an International Normalized Ratio (INR)≥ 1.5.
. Patient with serum creatinine level ≥104 µmol/L at time of enrolment.
. Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction at time of enrolment
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
eCLIPs Bifurcation Remodelling System Technical Success
Timeframe: 24 hours
2
No participant incurs a major stroke or death within 30 days or major territorial stroke or neurological death within 6 months.