Sequent Medical announced that it has commenced patient enrollment in a study to evaluate the safety and effectiveness of the WEB aneurysm embolization system specifically for the treatment of ruptured intracranial aneurysms.
Prof Laurent Spelle, MD, Head of Neuroradiology at Bicetre University Hospital, in Paris, France and Principal Investigator of the CLARYS study, enrolled the first patient.
The study, the CLinical Assessment of WEB device in Ruptured aneurYSms ("CLARYS"), will enroll 50 patients with ruptured aneurysms at up to 15 sites in France and Germany.
Although patients with ruptured aneurysms have been included in previous WEB studies, CLARYS will be the first prospective, multi-center study focused exclusively on gathering data on the WEB system in this patient population. Ruptured aneurysms currently comprise over half of all aneurysms treated globally.
The primary endpoint of the study will be the rate of aneurysm re-bleeding at 30 days. An independent core lab will review all study data and CLARYS will also feature independent clinical event adjudication.
The WEB device consists of a dense mesh constructed from a large number of extremely fine Nitinol wires, and functions as an intrasaccular flow disruptor, bridging the neck of the aneurysm and providing rapid, peri-procedural stasis.
"The combination of rapid and durable stasis, a safe, fast procedure and the avoidance of long term dual antiplatelet therapy makes the WEB an ideal treatment option for ruptured aneurysms," stated Prof Spelle.
"The initiation of the CLARYS study represents the next important milestone for this exciting technology platform and a critical step towards improving outcomes in a large patient population with significant unmet needs."
"The CLARYS study is the latest chapter in our ongoing commitment to build a solid foundation of clinical evidence for the WEB system, which includes three other European prospective, multicenter studies (WEBCAST, French Observatory, and WEBCAST 2), a US IDE study (WEB-IT), 30 peer-reviewed publications, and over 2,500 patients treated with the WEB," said Sequent President and CEO Tom Wilder.
"At Sequent Medical, we pride ourselves not only on groundbreaking technical innovation, but also on robust scientific evidence."