Safety Study of the PulseRider® in Patients Undergoing Treatment for Bifurcation Intracranial Ane… (NCT02435823) | Clinical Trial Compass
CompletedNot Applicable
Safety Study of the PulseRider® in Patients Undergoing Treatment for Bifurcation Intracranial Aneurysms
Austria35 participantsStarted 2015-03-31
Plain-language summary
This is a prospective multi-center, single arm, non-randomized study. It is designed to evaluate the safety of the PulseRider® in patients undergoing treatment for bifurcation 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
. Patient who presents with an MRA, CTA or angiographically confirmed, wide neck (\> 4 mm or dome to neck ratio \< 2) intracranial aneurysms located at a bifurcation
. The target aneurysm is in a vessel with a diameter of 2.7 mm to 4.5mm.
. The patient is 18 years or older at the time of consent
. The patient has signed the IRB/EC approved informed consent form
. In the opinion of the physician, placement of the PulseRider is technically feasible and clinically indicated
. Subject has mental capacity and is willing and able to comply with protocol requirements and follow-up
Exclusion criteria
. Unstable neurological deficit (condition worsening within the last 90 days)
. Subarachnoid Hemorrhage (SAH) within the last 60 days
. Irreversible bleeding disorder
. mRS score ≥3
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
Safety: Death or stroke in downstream territory
Timeframe: to 180-days post-procedure
2
Technical Success
Timeframe: at the time of the procedure
3
Rate of aneurysm occlusion
Timeframe: Day zero (within 24 hours post procedure) and 180-days