Recruitment

Recruitment Status
Unknown status
Estimated Enrollment
139

Inclusion Criteria

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

Exclusion Criteria

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

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

Exclusion Criteria

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

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
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