|Principal Investigator: Phil Taussky|
|Keywords: Cerebral Aneurysm||Department: Radiology Clinical|
|IRB Number: 00063670||Co Investigator:|
|Specialty: Radiology/Interventional, Neurosurgery|
|Sub Specialties: Neurointerventional Radiology, Cerebral Aneurysms|
A multi-center, prospective, non-randomized trial to evaluate the safety and effectiveness of the Surpass™ Flow Diverter compared to a historical control in the treatment of large or giant wide neck intracranial aneurysms
SCENT is a single-arm study of large or giant intracranial aneurysms with a wide neck in which subjects will be implanted with the Surpass™ Flow Diverter. Current common therapies, such as, glue, coiling and surgical clipping are not able to treat intracranial aneurysms with wide necks. The risk of rupture, failed occlusion, and complications during endovascular or surgical treatment for these types of aneurysms is high. Treatment options for these aneurysms are extremely limited; as described above, the long-term success rate for these intracranial aneurysms is low.
In this study, patients with intracranial aneurysms (IA) in the internal carotid artery that are considered untreatable by coils will be invited to participate in the study.
The objective of this study is to determine the safety and effectiveness of the SurpassTM Flow Diverter in the endovascular treatment of large or giant wide-necked intracranial aneurysms (IA) in internal carotid artery up to the terminus.
The Surpass NeuroEndoGraft™(NEG) system was developed to address the clinical need to treat large or giant wide neck intracranial aneurysms that are not amenable to surgical or current standard endovascular treatment due to location, morphology or known risks. The Surpass NeuroEndoGraft™ System consists of the implantable Surpass NeuroEndoGraft™ that is preloaded on a delivery catheter system. The device is designed to be placed into the parent artery across the neck of an aneurysm to divert blood flow away from the aneurysm. The product has been evaluated both preclinically and clinically and has received commercial CE Mark (December 2010) in the European Union. The results of these evaluations have demonstrated overall product safety and a pivotal IDE clinical study is proposed to be conducted in the United States and other countries to treat large or giant wide neck aneurysms. SCENT is a single-arm study of large or giant intracranial aneurysms with a wide neck in which subjects will be implanted with the Surpass NeuroEndoGraft™. Current common therapies, such as, glue, coiling and surgical clipping are not able to treat intracranial aneurysms with wide necks. The risk of rupture, failed occlusion, and complications during endovascular or surgical treatment for these types of aneurysms is high. Treatment options for these aneurysms are extremely limited; as described above, the long-term success rate for these intracranial aneurysms is low. In this study, patients with intracranial aneurysms (IA) in the internal carotid artery that are considered untreatable by coils will be invited to participate in the study.
Prior to enrollment in this study, candidates must meet ALL of the following criteria:
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
Candidates must be excluded from this study if ANY of the following criteria are met:
1. Known allergy or contraindication to aspirin, clopidogrel/Plavix, heparin, local or general anesthesia
2. Known history of life threatening allergy to contrast dye
3. Known allergy to nickel, chromium cobalt, tungsten or platinum.
4. Subject has documented resistance to clopidogrel/Plavix.
5. Major surgery within previous 30 days or planned in the next 120 days after enrollment date
6. Previous intracranial implant associated with the symptomatic distribution within the past 12 weeks prior to treatment date
7. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment date
8. Any previous stenting of parent artery at or proximal to the aneurysm where it would interfere with the placement and proper apposition of the device
9. Any previous coiling where it would interfere with the placement and proper apposition of the device
10. Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction
11. More than one intracranial aneurysms (IA) that requires treatment within 12 months
12. Asymptomatic extradural aneurysms requiring treatment
13. Contraindication to CT scan or MRI
14. Severe neurological deficit that renders the subject incapable of living independently
15. Unstable neurological deficit (i.e worsening of clinical condition in the last 30 days)
16. Evidence of active infection at the time of treatment
17. Dementia or psychiatric problem that prevents the subject from completing required follow up
18. Co-morbid conditions that may limit survival to less than 24 months
19. Serum creatinine ≥2.5 mg/dL
20. Female subjects who are pregnant or planning to become pregnant within the study period (all females of child bearing age must take a pregnancy test within 24 hours of treatment) and who are unwilling or unable to take adequate method of contraception for at least until the 12 months study follow up
21. Subject with anatomy not appropriate for endovascular treatement due to severe intracranial vessel tortuosity or stenosis
22. Extra-cranial stenosis or parent vessel with stenosis >50% in the area proximal to the aneurysm
23. Other known serious concurrent medical conditions such as heart disease (e.g. atrial fibrillation/pacemaker, recent myocardial infarction, symptomatic congestive heart failure, or carotid stenosis), pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, vasculitis, or subjects using immunosuppressants including corticosteroids.
24. History of intracranial vasospasm not responsive to medical therapy
25. Subject with an intracranial mass (tumor, except meningioma, abscess, or other infection), or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
26. Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions
27. Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date
28. Subject has a non-treated arterio-venous malformation (AVM) in the territory of the target aneurysm
29. Inability to understand the study or a history of non-compliance with medical advice
30. Current use of illicit substance
31. Enrollment in another trial involving an investigational product
32. Subject has a need for long-term use of anticoagulants (i.e. Warfarin, Dabigatran)