Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
139

Inclusion Criteria

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.
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.

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 is pregnant
...
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 is pregnant
Patient has an IA with characteristics unsuitable for endovascular treatment
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 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.
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.

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 is pregnant
...
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 is pregnant
Patient has an IA with characteristics unsuitable for endovascular treatment
Patient has stroke-in-evolution within the prior 60 days

Locations

Morgantown, West Virginia, 26505
Albany, New York, 12208
Budapest, 1145
Baltimore, Maryland, 21287
Minneapolis, Minnesota, 55407
...
Morgantown, West Virginia, 26505
Albany, New York, 12208
Budapest, 1145
Baltimore, Maryland, 21287
Minneapolis, Minnesota, 55407
Buffalo, New York, 14203
Philadelphia, Pennsylvania, 19107
Charleston, South Carolina, 29425
Englewood, Colorado, 80112
Memphis, Tennessee, 38120
Istanbul
Jacksonville, Florida, 32207
Aliso Viejo, California, 92565
Boston, Massachusetts, 02111
Columbus, Ohio, 43214
Knoxville, Tennessee, 37916
Memphis, Tennessee, 38104
Houston, Texas, 77030
Louisville, Kentucky, 40202
Rochester, Minnesota, 55905
Boston, Massachusetts, 021115
Houston, Texas, 77030
New York, New York, 10029
Phoenix, Arizona, 85013
Ankara
Stony Brook, New York, 11794
Erfurt, 99028
Chicago, Illinois, 60612
Charlotte, North Carolina, 28204
Copenhagen, 2100
Salt Lake City, Utah, 84132
Saskatoon, Saskatchewan, S7N 0W8

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