The phenox pREset and pREset LITE thrombectomy devices have been included in the study portfolio of the SITS Open clinical trial. Two other devices are included in the trial.
According to a company release, the positive outcomes of recent randomised clinical trials for mechanical thrombectomy such as MR CLEAN, ESCAPE, EXTEND IA and SWIFT PRIME have renewed interest in studies enrolling a large number of patients—studies such as SITS Open. 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.
According to the Department of Neuroscience at Karolinska Institute (Stockholm, Sweden), sponsors of the trial, 194 patients have been enrolled in the open, prospective, international, multicenter, controlled clinical trial as of 8 March 2016. The protocol calls for enrolling 600 patients in total, 300 in each arm. Patients enrolled in the treatment arm will be done so at centres that currently perform thrombectomy for stroke and fulfil the quality and training criteria for neuro-interventions. Patients in the control arm will be enrolled by clinics which offer IV thrombolysis and neither practice thrombectomy nor refer patients with ischemic stroke to other clinics where thrombectomy is offered.
phenox’ Managing Director,–Ing Hermann Monstadt says, “Given the growing evidence regarding the effectiveness of mechanical thrombectomy, it is very important that pREset and pREset LT are a part of the tools available to physicians in treating ischaemic stroke.”