The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms

Study ID
STU 112012-010

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
Babu Welch

Summary

Prospective multi-center single arm study of large or giant intracranial aneurysms with a wide neck in which subjects will be imlanted with the Surpass Flow Diverter. Patients who have been referred to the investigators and who meet the study inclusion/exclusion criteria will be invited to participate. Subjects will be allowed to review the informed consent for a minimum of 24 hours. Subjects who agree to participate will undergo the following:

1. Screening/Baseline period
a. informed consent by an investigator
b. Clopidogrel Resistance Testing (blood test)
c. Pregnancy test
d. Physical assessment including vital signs
e. Medical history review
f. neurological evaluations including a neurologic exam, cranial nerve exam, Stroke scale exam (niHSS), mRS ranking for neurologic injury.
g. Review of medication
h. Blood tests (red and white blood count, hematocrit, platelet count, prothrombin time, PTT, inR and creatinine) if not previously available in 7 days.
i. cerebral arteriogram (if not previously performed within 6 months)
j. visual exam (only for opthalmic artery aneurysms
2. Treatment period/Pre-discharge
a. embolization procedure (includes angiogram) with the Surpass neuroendograft device
b. 24 hour inpatient hospital including a night in the intensive care.
c. neurological evaluations including a neurologic exam, cranial nerve exam, Stroke scale exam (niHSS), mRS ranking for neurologic injury.
3. Thirty day
neurological evaluations including a neurologic exam, cranial nerve exam, Stroke scale exam (niHSS), mRS ranking for neurologic injury.
4. 6 month, 12 month, 2,3,4,5 years post procedure
neurological evaluations including a neurologic exam, cranial nerve exam, Stroke scale exam (niHSS), mRS ranking for neurologic injury.
5. 6 months, 12 months, 3 and 5 years post procedure
Cerebral arteriogram

Participant Eligibility

1. Age 19 to 80 years
2. Subject or legal representative is willing and able to give informed consent
3. Subject has a single targeted intracranial aneurysm that:
a. Is located in the internal carotid artery (ICA) distribution up to the terminus
b. Is able to be crossed with a standard 0.014
* guide wire
c. Has a neck >4 mm or no discernible neck and an aneurysm size >10 mm (including saccular, fusiform and dissecting configuration)
d. Has a vessel diameter between 2.5 mm and 5.3 mm at both the proximal and distal segments where the implant will be placed
4. Subject agrees to return to the treating Investigator for all scheduled follow up visits and is capable of returning to the hospital for follow up