Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms

Study ID
SP-04

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern Ambulatory Services
  • Zale Lipshy University Hospital

Contact
Kim Dutton-Johnson
214/645-7046
kim.dutton@utsouthwestern.edu

Principal Investigator
Babu Welch

Official Title

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

Brief Overview


This clinical research study is designed to determine safety and effectiveness of the
Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide
neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the
wall of a blood vessel in the brain. The bulge is caused by a weakening of the vessel wall.
If left untreated, the bulge may continue to grow larger and ultimately the vessel may break
open (rupture), resulting in serious bleeding into our around the brain. The information
collected from this study will be used to evaluate how well patients do when treated with
the Surpass System both immediately after treatment of an aneurysm and over a long period of
time (5 years).

Summary


The objective of this study is to determine safety and effectiveness of the Surpass Flow
Diverter (Surpass System) in the endovascular treatment of large or giant wide-necked
intracranial aneurysms in the internal carotid artery up to the terminus. The Surpass Flow
Diverter is an intracranial implant designed to be placed in a parent artery so as to divert
blood flow away from an aneurysm. Use of the Surpass System may be associated with a
decrease in neurological death or ipsilateral stroke in patients with large or giant
wide-neck aneurysms. In a given patient, the Surpass System will be deemed effective if
treatment results in complete occlusion of their aneurysm without clinically significant
stenosis of the parent artery at one year.

Participant Eligibility


Inclusion Criteria:

- Subject understands the nature of the procedure and provides written informed consent

- Subject is willing to return to the investigational site for all scheduled follow-up
visits

- Subject is 19 to 80 years of age

- Subject has a single targeted intracranial aneurysm

Exclusion Criteria:

- Pregnancy

- Enrollment in another trial

- Allergy or contraindication to aspirin, Clopidogrel/Plavix, heparin, local or general
anesthesia

- History of life threatening allergy to contrast dye

- Known allergy to nickel, chromium cobalt, tungsten or platinum.

- Major surgery within previous 30 days or planned in the next 120 days after
enrollment date

- Severe neurological deficit that renders the subject incapable of living
independently

- Dementia or psychiatric problem that prevents the patient from completing required
follow up

- Co-morbid conditions that may limit survival to less than one year

- Subject with anatomy not appropriate for endovascular treatment due to severe
intracranial vessel tortuosity or stenosis, or a history of intracranial vasospasm
not responsive to medical therapy

- Subject with an intracranial mass, or is undergoing radiation therapy for carcinoma
or sarcoma of the head or neck region

- Subject has a history of bleeding diathesis or coagulopathy, international normalized
ratio (INR) greater than 1.5, or will refuse blood transfusions

- Subject has a serum creatinine level greater than 2.5mg/dL (within 7 days of
procedure) which the investigator determines restricts the use of contrast agents

- Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral
artery) or intracranial artery within 30 days prior to treatment date

- Subject has a previous intracranial implant associated with the symptomatic
distribution within the past 12 weeks prior to treatment date

- Subject has other known serious concurrent medical conditions such as heart disease,
pulmonary disease or uncontrolled diabetes

- Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date

- Subject with resistance to Clopidogrel

- Subject has a non-treated arteriovenous malformation (AVM) in the territory of the
target aneurysm