Recruitment

Recruitment Status
Not yet recruiting

Inclusion Criteria

Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures
Patient must have a single ruptured or unruptured IA requiring treatment
Patient must be ≥ 18 at the time of screening
Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures
Patient must have a single ruptured or unruptured IA requiring treatment
Patient must be ≥ 18 at the time of screening

Exclusion Criteria

Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
Patient is pregnant
...
Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
Patient is pregnant
Patient index IA was previously treated
Patient has an IA with characteristics unsuitable for endovascular treatment

Summary

Conditions
Wide Neck Bifurcation Intracranial Aneurysms
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures
Patient must have a single ruptured or unruptured IA requiring treatment
Patient must be ≥ 18 at the time of screening
Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures
Patient must have a single ruptured or unruptured IA requiring treatment
Patient must be ≥ 18 at the time of screening

Exclusion Criteria

Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
Patient is pregnant
...
Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
Patient is pregnant
Patient index IA was previously treated
Patient has an IA with characteristics unsuitable for endovascular treatment

Tracking Information

NCT #
NCT04839705
Collaborators
Not Provided
Investigators
  • Principal Investigator: Adam Arthur, MD Methodist University Hospital, Memphis TN Principal Investigator: David Fiorella, MD Stony Brook University, Stony Brook NY
  • Adam Arthur, MD Methodist University Hospital, Memphis TN Principal Investigator: David Fiorella, MD Stony Brook University, Stony Brook NY