Rationale: Large & Giant aneurysms re-canalize (30% -50%) Hypothesis: Concentric filling with Presidio in conjunction with other Cerecyte coils yields a lower re-canalization rate in large & giant aneurysms compared to historical data.   Objective: To assess the angiographic outcomes and morbidity-mortality of EVT of large and giant aneurysms using Cerecyte coils and a minimum of one Presidio coil used as a framing coil. To add to clinical research data that guides evidence based decision making in EVT of large and giant aneurysms.

Protocol Overview:

• Prospective, non-randomized, single arm multi-center registry
• Non-experimental: Care is per standard treatment guidelines
• Designed to document the immediate and 12 month angiographic rates using modified Raymond-Roy grading scale (RRGS)
• 24 months; maximum of 200 patients from 30 global sites
  
  

Inclusion Criteria:

• Patient informed consent obtained
• Subject age ≥ 18 and ≤ 80 with a diagnosis of ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion Patient opts for coiling treatment
• Aneurysm size [largest measurement from the cross sectional images to determine overall aneurysm size not just the lumen] ≥ 10 mm.
• If ruptured aneurysm: Subject grade WFNS < 4 or Subject grade Hunt and Hess < 4
• If unruptured aneurysm: Subject grade Modified Rankin Scale mRS <  4
• A minimum of one Presidio coil used
  
  

Exclusion Criteria:

• Prior treatment (surgical or endovascular) of the aneurysm
• Patient with social, medical or psychological conditions preventing him to follow treatment and evaluation procedure of the registry.
• Women who are pregnant or plan to get pregnant during the Study
• Fewer than 75% Cerecyte coil length utilized during the procedure
• Use of other modified coils (Matrix,  Hydro or fibered coils)
• Use of liquid embolic material
• Terminal stage brain tumor
• Presence of AVM, Fusiform, mycotic or traumatic aneurysms
• Aneurysm treated by vessel occlusion
• Enrolled in any concurrent Study, that may confound the results of this Study
  
  

Schedule of Assessments:

Endpoints for Effectiveness:

• Primary:
  Immediate and 12 month angiographic occlusion rates assessed using the modified Raymond-Roy grading scales

• Secondary:
  Morbidity and mortality
  Retreatment rate
  Neurological outcome
  Cost of procedure (Number of Coils)
  Packing density
  Recurrence rate
  
  

Current Active Sites:

Contact Information:

If you would like more information about the study, please feel free to contact us:

Meg Guilhermier
Director of Clinical Research
mguilhermier@micruscorp.com