Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT02312856
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 \< 100 x 103 cells/mm3
* Inability to tolerate, adverse reaction or contraindication to taking aspirin or clopidogrel
* A history of contrast allergy that cannot be medically controlled
* Known allergy to nickel
* Relative contraindication to angiography (e.g., serum creatinine \> 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02312856
Study Brief:
Protocol Section:
NCT02312856