Mode
Text Size
Log in / Sign up
N/A N=34 Treatment

Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction

Intracranial Aneurysms

Enrolled (actual)
34
Serious AEs
35.3%
Results posted
Mar 2019
Primary outcome: Primary: Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death — 0; 29 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
PulseRider (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Pulsar Vascular
Primary completion
Oct 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death
0; 29

Summary

This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus aneurysms.

Eligibility Criteria

Inclusion Criteria

  • Patient who presents with an angiographically confirmed, wide neck intracranial aneurysms located at a bifurcation of the basilar artery or carotid terminus artery
  • The target aneurysm is in a vessel with a diameter of 2.7 mm to 4.5 mm.
  • 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 2.5 mg/dL)
  • Woman with child-bearing potential who cannot provide a negative pregnancy test
  • Evidence of active infection
  • Other conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events
  • Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 365-day follow-up period
  • Extracranial stenosis greater than 50% in the parent artery requiring access to the lesion
  • Intracranial stenosis greater than 50% in the treated vessel
  • Extreme vessel tortuosity that prohibits appropriate control of the micro-guide wire and/or the PulseRider delivery wire
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02312856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search