Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-006476
- Jacksonville, Florida: 12-006476
NCT ID: NCT01716117
Sponsor Protocol Number: SP-04
About this study
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).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Giuseppe Lanzino, M.D. |
Closed for enrollment |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Rabih Tawk, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available