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 range18 Years – 80 Years

SexALL

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
✕. Irreversible bleeding disorder
✕. Patient has another intracranial aneurysm that in the Investigator's opinion, may require treatment within the 1 year follow up period
✕. A history of contrast allergy that cannot be medically controlled
✕. Known allergy to nickel
✕. Relative contraindication to angiography
✕. Woman of child-bearing potential who cannot provide a negative pregnancy test

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 range18 Years – 80 Years

SexALL

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
✕. Irreversible bleeding disorder
✕. Patient has another intracranial aneurysm that in the Investigator's opinion, may require treatment within the 1 year follow up period
✕. A history of contrast allergy that cannot be medically controlled
✕. Known allergy to nickel
✕. Relative contraindication to angiography
✕. Woman of child-bearing potential who cannot provide a negative pregnancy test

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