Evasc Neurovascular has announced enrolment of the first patient in its eClips safety, feasibility and efficacy study (EESIS-FR) in France. The study will be conducted with the objective of evaluating the technical feasibility, safety and efficacy of the company’s eClips products for the treatment of bifurcation aneurysms.
Up to 28 neurointerventional sites across France will enrol patients in this study. Procedural success with the second-generation eClips bifurcation remodelling system will be evaluated to determine its feasibility, while safety outcomes will be measured via major stroke or death within 30 days, or major territorial stroke or neurological death within one year.
Additional endpoints will be evaluated in the study, according to Evasc, and data are also set to be collected to assess procedural success and record efficacy information on other eClips products.
“I am pleased to have enrolled the first patient in this important clinical study to help further the clinical understanding of the real-world effectiveness of the second-generation eClips aneurysm treatment system,” said Raphaël Blanc, principal investigator of the study, and consultant interventional neuroradiologist and deputy head at the Department of Interventional Neuroradiology at Rothschild Foundation Hospital in Paris, France.
“We have seen an enormous improvement in the second-generation eClips delivery system: stability and placement within eight minutes is a gamechanger in the neurointerventional practice.”
The eClips device has been granted ‘innovative’ status in the French Forfait Innovation programme, and the study is partially funded by the French National Authority for Health (Haute Autorité de Santé [HAS]) within this programme.