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 range18 Years

SexALL

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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
✕. Patient has another aneurysm which, in the Investigator's opinion, will require treatment within the follow up period (365 days)
✕. Platelet count \< 100 x 103 cells/mm3or known platelet dysfunction
✕. Inability to tolerate, adverse reaction or contraindication to taking aspirin or clopidogrel
✕. A history of contrast allergy that cannot be medically controlled

What they're measuring

Safety: Death or stroke in downstream territory

Timeframe: to 180-days post-procedure

Technical Success

Timeframe: at the time of the procedure

Rate of aneurysm occlusion

Timeframe: Day zero (within 24 hours post procedure) and 180-days

Trial details

NCT IDNCT02435823

SponsorPulsar Vascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12-31

View on ClinicalTrials.gov More Brain Aneurysm trials