Recruitment

Recruitment Status
Unknown status
Estimated Enrollment
139

Inclusion Criteria

Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.
Patient must have a single ruptured or unruptured IA (intracranial aneurysm) requiring treatment.
Patient whose age ≥18 and ≤75 years.
Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.
Patient must have a single ruptured or unruptured IA (intracranial aneurysm) requiring treatment.
Patient whose age ≥18 and ≤75 years.

Exclusion Criteria

Patient has an IA with characteristics unsuitable for endovascular treatment
Patient's index IA was previously treated
Patient has stroke-in-evolution within the prior 60 days
...
Patient has an IA with characteristics unsuitable for endovascular treatment
Patient's index IA was previously treated
Patient has stroke-in-evolution within the prior 60 days
Patient has had an SAH (subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days
Patient is pregnant

Summary

Conditions
  • Intracranial Aneurysms
  • 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 75 years
Gender
Both males and females

Inclusion Criteria

Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.
Patient must have a single ruptured or unruptured IA (intracranial aneurysm) requiring treatment.
Patient whose age ≥18 and ≤75 years.
Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.
Patient must have a single ruptured or unruptured IA (intracranial aneurysm) requiring treatment.
Patient whose age ≥18 and ≤75 years.

Exclusion Criteria

Patient has an IA with characteristics unsuitable for endovascular treatment
Patient's index IA was previously treated
Patient has stroke-in-evolution within the prior 60 days
...
Patient has an IA with characteristics unsuitable for endovascular treatment
Patient's index IA was previously treated
Patient has stroke-in-evolution within the prior 60 days
Patient has had an SAH (subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days
Patient is pregnant

Tracking Information

NCT #
NCT02191618
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