Framing Eighteen coils in cerebral Aneurysms Trial

Study ID
STU 072012-063

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Zale Lipshy University Hospital
  • Parkland Health & Hospital System

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

Principal Investigator
Babu Welch

Summary

Patients will be enrolled who meet the inclusion criteria and consent to participate. Patients will be randomly assigned by a central web-based system in a 1:1 manner to either the framing coil treatment or the non-framing coil treatment. Data on each patient will be collected at the time of enrollment and treatment, and at first (3-6 months)and second (12-18 months) follow-up visits.

Participant Eligibility

1. Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular treating team (neurointerventionist and/or neurosurgeon).
2. The neurointerventionist feels that the aneurysm can be safely treated with either using, or not using, a 0.014-0.0155
* platinum coil.
3. Patient is 18-80 years of age.
4. Patient must be Hunt and Hess grade 0 to 3.
5. Patient has given fully informed consent to endovascular coiling procedure. If the patient cannot consent for themselves, appropriate written consent has been sought from their authorized surrogate or appropriate power of attorney.
6. Aneurysm 6-14 mm in maximum diameter.
7. Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at 3-6 months and 12-18 months after endovascular treatment.
8. The patient has not been previously randomized into this trial or another related ongoing trial.
9. The aneurysm has not been previously treated by coiling or clipping.