Micrus Endovascular, a developer, manufacturer and marketer of implantable and disposable cerebral vascular devices, has presented the preliminary six-month follow-up data from the Cerecyte Coil Trial (CCT) which showed strong clinical outcomes for both Micrus Endovascular Cerecyte and bare platinum microcoils in the treatment of cerebral aneurysms.
Micrus said that the CCT trial is a prospective, randomized, multicenter clinical trial designed to show the superiority of polymer-filled Cerecyte microcoils and compare clinical outcomes and safety for patients with ruptured and un-ruptured cerebral aneurysms treated with either Micrus Cerecyte microcoils or with Micrus bare platinum microcoils.
The data were presented by CCT principal investigator Andrew Molyneux, Oxford Neurovascular & Neuroradiology Research Unit, University of Oxford, UK, at the 48th Annual American Society of Neuroradiology meeting in Boston.
As per the study, of the 500 patients recruited at 23 centers worldwide, 249 were randomized to the Micrus Cerecyte arm and 251 to the bare platinum arm.
Dr Molyneux had presented preliminary CCT outcomes utilising the modified Rankin Scale (mRS) for freedom from disability or dependence, or mRS =2. The mRS is a commonly used six-point scale for measuring the degree of disability or dependence in the daily activities of people who have had a stroke, and is the most widely used clinical outcome measure for stroke clinical trials. He also presented investigator-reported angiographic occlusion rates.
The clinical results demonstrated that 97% freedom from disability or dependence and 86% investigator-reported Angiographic Occlusion Rate at six months compare favorably with results from all published and reported randomized Endovascular Microcoil clinical trials.
The CCT trial design includes independent angiographic core lab assessment by Allan Fox, Sunnybrook HSC, Toronto, Canada, and adjudication of adverse events by medical reviewers blinded to the treatment modality utilized. The independent angiographic core laboratory assessment and adjudication are not yet complete. Dr Molyneux expects to submit final, full CCT trial data for publication in a peer-reviewed journal later this year.
John Kilcoyne, chairman and CEO of Micrus Endovascular, said: “Outcomes, occlusion rates and retreatment rates of procedures performed with Micrus microcoils whether Cerecyte or bare platinum are far superior to the seminal ISAT results, and we expect that interventionalists around the world will appreciate the outstanding clinical outcomes that Micrus coils deliver.
“The CCT results further validate our established role as a leader in endovascular microcoil technology, and support the ongoing conversion to Micrus coils. We also believe these data may accelerate the conversion from surgical intervention to minimally invasive coiling in patients with cerebral aneurysms.”