Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion Clinical Trial
Official title:
Merlin's DiVeRt-Vascular Reconstruction Device: a Prospective, Single Arm, Non-randomized, Open Label Study to Assess Safety and Performance
The objective of the proposed investigation is to assess the safety and effectiveness of the Merlin's DiVeRt system for the treatment of intracranial lesions. Merlin is a manufacturer of Flow- Diverters (FD) for Neurovascular applications. The technology is based on a microporous polymer membrane which is delivered to the site of lesion treatment using a metal stent scaffold. The first device in its FD family is the XCalibur Aneurysm Occlusion Device (AOD) system, which is delivered on a rapid-exchange balloon catheter which goes in a 6-Fr guide-catheter. The AOD is CE-marked and has been involved in the treatment of over 70 clinical lesion/aneurysm cases. The same technology is now being made available in a self-expandable stent platform delivered on a 0.028" microcatheter. Merlin has performed the required in-silico, in-vitro and in-vivo tests to be confident of the device performance and now intends to proceed to the human clinical-trials. DiVeRt (Interventional) is a non CE mark device. The device is under clinical trial phase. The competent authority submission for the study has been completed in Spain, Turkey and Hungary.
The study will recruit patients with intracranial aneurysm (IA) or a lesion located in the anterior or posterior circulation. The analyses of the data from this safety and feasibility study will be descriptive. ;