ATLAS Study

Condition

Study Name

Safety and Effectiveness of the Treatment of Wide-Neck, Saccular Intracranial Aneurysms with the Neuroform Atlas™ Stent System (IRB no. 40978)

Phase

Phase III

Summary

The purpose of this study is to evaluate the investigational use of the Neuroform Atlas Stent in patients with brain aneurysms. An aneurysm is a bulging (ballooning) of a blood vessel caused by a weakness in the vessel’s wall. A standard treatment option is to have a procedure called stent-assisted endovascular coiling, which involves inserting a tube into a blood vessel to place the stent and coils into the aneurysm. Researchers will collect data on the Neuroform Atlas Stent and examine its safety and effectiveness for use with embolic coils.

Eligibility

Key Inclusion Criteria:
  • Between 18 and 80 years old
  • Wide-neck, intracranial (within the skull), saccular (resembling a small sack) aneurysm which will be treated with bare metal coils
  • Willing and able to provide informed consent
Key Exclusion Criteria:
  • Known multiple, untreated brain aneurysms
  • Aneurysm in the front of brain next to the superior hypophyseal internal carotid artery
  • Admission platelet count of less than 50,000, any known coagulopathy (impaired ability of blood to clot), or an international normalized ratio greater than 3.0 without medication

Please see additional list of inclusion and exclusion criteria.

Principal Investigator

Michael Alexander, MD

Contact

Vicki Manoukian
Phone: 310-423-5067
Email: vicki.manoukian@cshs.org