Phenox's Preset Thrombectomy Devices Included in SITS Open Stroke Trial Protocol

March 14, 2016—Phenox GmbH announced its participation in the SITS Open clinical trial in which the company’s Preset and Preset Lite thrombectomy devices have been included in the study device portfolio. Preset is one of three devices to be used in the study.

According to the company, with the positive outcomes of recent randomized clinical trials for mechanical thrombectomy such as MR CLEAN, ESCAPE, EXTEND IA, and SWIFT PRIME, the SITS Open protocol is designed to provide a higher level of evidence for mechanical thrombectomy through a direct comparison between mechanical thrombectomy and a concurrent control of medical management alone.

The open, prospective, international, multicenter, controlled SITS OPEN clinical trial is designed to enroll 600 patients—300 in each arm. Patients in the treatment arm will be enrolled at centers that currently perform thrombectomy for stroke and fulfill the quality and training criteria for neurointerventions. Patients in the control arm will be enrolled by clinics that offer intravenous thrombolysis and that neither practice thrombectomy nor refer patients with ischemic stroke to other clinics where thrombectomy is offered, stated Phenox.

The SITS Open trial is sponsored by the Department of Neuroscience at Karolinska Institute in Stockholm, Sweden. SITS: Safe Implementation of Treatments in Stroke is an academic-driven, nonprofit, international collaboration with a base at Karolinska Institute that seeks to accelerate clinical trials and to certify excellence in acute and secondary prevention stroke treatment.