N/A
N=34
Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction
Intracranial Aneurysms
Bottom Line
View on ClinicalTrials.gov: NCT02312856 ↗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
| Outcome | Result | p-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
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.