A Prospective, Multicenter, Randomized, Double Blind, Placebo-Controlled Trial to Evaluate the Efficacy of Patent Foramen Ovale Closure with the STARFlex Septal Repair Implant to Prevent Refractory Migraine Headaches: the MIST Trial S61.002

Observational studies demonstrated that patent foramen ovale (PFO) closure in stroke and decompression sickness patients led to the resolution of migraine in 65-90% of patients. The MIST (Migraine Intervention with STARFlex® Technology) Trial is the first trial to attempt to investigate these observations with a prospective, double-blind, placebo-controlled design. Patients aged 18-60 years with migraine with aura (according to International Headache Society 1988 classification) that was refractory to two or more classes of prophylactic medications and who had a minimum of 5 migraine headache days and 7 headache-free days per month were recruited. Transthoracic contrast echocardiography was used to detect right-to-left shunts …