A Feasibility Study of the MicroVention, Inc. Neurovascular Self-Expanding Retrievable Stent System in the Treatment of Wide-Necked Intracranial Artery Aneurysms

Study ID
STU 062011-111

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern Ambulatory Services
  • UT Southwestern University Hospital– Zale Lipshy

Contact
Kim Dutton-Johnson
214-648-7815
kim.dutton@utsouthwestern.edu

Principal Investigator
Glenn Pride

Summary

Prospective multi-center single arm study
Four components:
1. Screening period
2. Treatment period
3. Thirty day clinical and neurological follow up
4. 6 month clinical neurological and angiographic follow up

Participant Eligibility

• Age between 18 and 80 years
• Unruptured wide-neck, saccular, intracranial aneurysm, < 20 mm maximum diameter in any plane
Wide-neck is defined as neck width > 4 mm or dome-to-neck ratio < 2
• Subject’s aneurysm arises from a parent vessel with a diameter of ≥ 2.5 mm and < 4.5mm
• Subject or his legal representative understands the nature of the procedure and provides signed informed consent form
• Subject is willing to return to the investigational site for the thirty day and six month follow up evaluation