Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
139

Inclusion Criterias

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 Criterias

Patient has an IA with characteristics unsuitable for endovascular treatment
Patient is pregnant
Patient's index IA was previously treated
...
Patient has an IA with characteristics unsuitable for endovascular treatment
Patient is pregnant
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

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 Criterias

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 Criterias

Patient has an IA with characteristics unsuitable for endovascular treatment
Patient is pregnant
Patient's index IA was previously treated
...
Patient has an IA with characteristics unsuitable for endovascular treatment
Patient is pregnant
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

Locations

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

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