European CLARYS Study Begins for Sequent Medical's Web Aneurysm Embolization System in Ruptured Intracranial Aneurysms

February 12, 2016—Sequent Medical, Inc. announced that it has commenced patient enrollment in the CLARYS study, which is evaluating the safety and effectiveness of the company’s Web aneurysm embolization system for the treatment of ruptured intracranial aneurysms. The first patient was enrolled by CLARYS Principal Investigator Prof. Laurent Spelle, MD, Head of Neuroradiology at Bicetre University Hospital in Paris, France.

According to Sequent Medical, the CLARYS study will enroll 50 patients with ruptured aneurysms at up to 15 sites in France and Germany. The company noted that although patients with ruptured aneurysms have been included in previous Web studies, CLARYS will be the first prospective, multicenter study focused exclusively on gathering data on the Web system in this patient population.

The primary endpoint of the study will be the rate of aneurysm rebleeding at 30 days. An independent core lab will review all study data and CLARYS will also feature independent clinical event adjudication.

Sequent Medical stated that the Web device is composed of a dense mesh that is 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, periprocedural stasis. 

In the company’s announcement, Prof. Spelle commented, “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. 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 part of the company’s clinical investigation program for the Web device that includes three other European prospective, multicenter studies (WEBCAST, French Observatory, and WEBCAST 2), and a United States investigational device exemption study (WEB-IT).

The Web aneurysm embolization system and the company’s Via microcatheter have both received European CE Mark approval. In the United States, the Via microcatheter has been cleared for commercial use; the Web system is an investigational device limited to investigational use, advised Sequent Medical.