Cerecyte Coil Trial: A randomised trial of polymer loaded detachable platinum compared with standard platinum coils in treatment of intracranial aneurysms Chief Investigator: Andrew J Molyneux MD Rationale: To systematically evaluate the clinical and angiographic outcome of intracranial aneurysm embolisation using the Micrus Cerecyte (polymer loaded) coil system. Primary Hypothesis Micrus Cerecyte coils produce superior angiographic occlusion rates at 6 months after treatment compared with bare platinum coils in patients undergoing endovascular platinum coil treatment for cerebral aneurysms. Secondary Hypothesis The rate of procedural and clinical complications does not differ between bare platinum coils and polymer loaded coils. A healing reaction is seen in a proportion of patients treated with Cerecyte coils and in no patients treated with standard platinum coils

Primary Objective

• To determine if Cerecyte (polymer loaded) coils improve the proportion of patients with angiographic occlusion of the aneurysm at 6 months by 50%,  from a rate of 75% to 87.5% as set out in the definition of success.
  
  

Secondary Objectives

• The determine if the rate of procedural complications or other adverse events is the same with bare platinum coils as with Cerecyte coils.
• To determine if the need for re-treatment of the aneurysm is reduced
• To determine if a “healing reaction” is seen in a proportion of patients treated with polymer loaded coils and in no patients treated with standard platinum coils
  
  

Sample Size

• Power calculations suggest 250 patients in each group for 0.05 significance at 80% Power
• Allowing for patient attrition from death/poor outcome or default from follow up angiogram assessment
• 500 patients recruited
• Safety analysis by Data Monitoring Committee after 150 outcomes
• Up to 20 centres
  
  

Definition of Success:

• Complete angiographic occlusion, improvement or no change in the angiographic appearances from the post procedural angiography, as determined by the core lab.
• The core lab (coordinated by Alan Fox, MD) blinded to the coil used. Follow-up intra-arterial angiography performed between 5 and 7 months after treatment. Any deterioration in angiographic appearances will be defined as failure and the need for re-treatment will be defined as failure.
  
  

What will the Trial Achieve?

• Determine present safety and efficacy standard for coil treatment of UIA and RIA.
• Data can be pooled with HELPS to increase power
• An accurate comparison of angiographic outcomes and establish if Cerecyte produces superior occlusion rates
• Demonstrate the up to date occlusion rates for the coil treatment of aneurysms
• Demonstrate current clinical outcomes in treatment of UIA and good grade SAH patients following coiling in experienced centres
• Set proper standards for the conduct of clinical trials in the INR community.
  
  

Current Active Sites:

Coordinating centre Neurovascular Research Unit, Oxford (ISAT office)
Mary Sneade, Trial coordinator
20 Participating centres

Current Sites

 

Contact Information:

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

Mary Sneade
Clinical Trial Manager
University of Oxford
mary.sneade@nds.ox.ac.uk