Overview Leaders Free Japan Status: Unknown status Trial end date: 2017-07-01 Target enrollment: Participant gender: Summary Prospective, multi-center, non-randomized, open-label trial designed to enroll 139 patients in Japan. All patients will receive a DCS and will be followed for 2 years. Phase: Phase 3 Details Lead Sponsor: Biosensors Europe SACollaborator: Biosensors Japan Co. Ltd.