TerminatedPhase 3

A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm

Stopped: No safety issues; change in innovation strategy

United States21 participantsStarted 2018-10-15

Plain-language summary

This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.

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

. Subject with wide neck intracranial aneurysm located at a bifurcation
. The subject is between 18 and 80 years of age the time of consent
. Informed consent is obtained and the subject signs the IRB approved consent prior to beginning any study procedures
. In the opinion of the treating physician, placement of the PulseRider® device is technically feasible and clinically indicated

Exclusion criteria

. Unstable neurological deficit (condition worsening within the last 90 days)
. Subarachnoid Hemorrhage (SAH) within the last 60 days

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

Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure

Timeframe: Up to 1 year post procedure

Percentage of Participants With Occurrence of Neurological Death or Major Ipsilateral Stroke in Downstream Territory up to 1 Year Post-procedure Per Clinical Events Committee (CEC)

Timeframe: Up to 1 year post procedure

Trial details

NCT IDNCT03383666

SponsorPulsar Vascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-12

Results submitted2021-10-21

View on ClinicalTrials.gov More Unruptured Wide-neck Intracranial Aneurysms trials

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

. Subject with wide neck intracranial aneurysm located at a bifurcation
. The subject is between 18 and 80 years of age the time of consent
. Informed consent is obtained and the subject signs the IRB approved consent prior to beginning any study procedures
. In the opinion of the treating physician, placement of the PulseRider® device is technically feasible and clinically indicated

Exclusion criteria

. Unstable neurological deficit (condition worsening within the last 90 days)
. Subarachnoid Hemorrhage (SAH) within the last 60 days

What they're measuring

Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure

Timeframe: Up to 1 year post procedure

Percentage of Participants With Occurrence of Neurological Death or Major Ipsilateral Stroke in Downstream Territory up to 1 Year Post-procedure Per Clinical Events Committee (CEC)

Timeframe: Up to 1 year post procedure