ARISE II Pivotal Trial Begins for Neuravi's EmboTrap Stent Retriever

November 5, 2015—Neuravi announced the commencement of the pivotal ARISE II international clinical trial to assess the safety and effectiveness of the company’s EmboTrap revascularization device, which is a stent retriever for the treatment of acute ischemic stroke. 

According to Neuravi, the ARISE II study will enroll 210 patients at up to 25 sites across Europe and the United States. Data from the study will be submitted as part of an application to the US Food and Drug Administration for approval for the device.

The EmboTrap thrombectomy device is engineered to retrieve and retain the clot with a dual-layer, stent-like structure, while restoring blood flow to the brain. The device’s integrated distal protection zone is designed to reduce the risk of fragments of the clot escaping during retrieval. The device has received CE Mark approval and is commercially available in Europe. The company advised that it is available for investigational use only in the United States. 

The study’s first patient was enrolled by Tennessee Interventional and Imaging Associates at the Southeast Regional Stroke Center at Erlanger Medical Center in Chattanooga, Tennessee. The center is a Joint Commission–certified comprehensive stroke center that has played a leadership role in international clinical trials for stroke treatment.

Blaise Baxter, MD, Chief of Radiology at Erlanger, commented in Neuravi’s press release, “We are pleased to treat the first patient in this international trial of a cutting-edge technology that may offer advantages over currently available devices. Evaluating new technology with the goal of improving patient outcomes is all part of our effort to deliver the best patient care possible.”

Sam Zaidat, MD, and Prof. Tommy Andersson, MD, are the study’s principal investigators in the United States and Europe, respectively. Dr. Zaidat is Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital in Toledo, Ohio. Prof. Andersson is from the Karolinska Institute in Stockholm, Sweden. 

Neurologists Jeff Saver, MD, of UCLA Medical Center in Los Angeles, California, and Heinrich Mattle, MD, of Inselspital in Bern, Switzerland, serve on the study’s initiating executive steering committee.

In Neuravi’s press release, Dr. Zaidat commented, “Stroke care has entered a new age. Now that multiple trials have demonstrated the value of endovascular therapy for treating acute ischemic stroke, we are looking for ways to further improve patient care through new technology, better techniques, and streamlined systems. The ARISE II trial is the first investigational device exemption clinical trial to evaluate innovative stent retriever technology in this new era for stroke.”