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REDUCER-I

  • Research type

    Research Study

  • Full title

    REDUCER-I: An Observational Study of the Neovasc Reducerâ„¢ System

  • IRAS ID

    190140

  • Sponsor organisation

    Neovasc Inc.

  • Clinicaltrials.gov Identifier

    NCT02710435

  • Duration of Study in the UK

    7 years, 1 months, 1 days

  • Research summary

    The Reducer-I study is a multicenter, international, three-arm prospective and retrospective observational study conducted at a maximum of 40 investigational centers. The purpose of the study is to collect long term data on outcomes with the Reducer device. \nThe Reducer is intended for patients with refractory angina pectoris despite medical therapy, who are either not amenable or are at high risk for revascularization by coronary artery bypass grafting (CABG) or by percutaneous coronary intervention (PCI). Subjects included in the study will be those with refractory angina pectoris who have reversible myocardial ischemia, have limited or no options for revascularization, or subjects who have received the Reducer device in the COSIRA study, or under CE Mark prior to the REDUCER-I study.\nThe study consists of 3 study arms. Data will be collected at baseline, implant procedure, 30 days, 6 and 12 months post implant and annually through 5 years for all study arms.\nArm 1: Subjects are consented / enrolled prior to receiving the Reducer. \nArm 2: Subjects who were previously enrolled and treated with the Reducer during the COSIRA study will be invited to participate. This study arm will collect both retrospective (prior to consent) and prospective (after consent) data. \nArm 3: Subjects who received a Reducer under CE Mark (unrelated to the COSIRA study) will be invited to participate. \nIn Arm 1, new (prospective) data will be collected and in Arms 2 and 3, both existing and new data will be collected.\n

  • REC name

    London - Stanmore Research Ethics Committee

  • REC reference

    16/LO/0324

  • Date of REC Opinion

    9 Mar 2016

  • REC opinion

    Further Information Favourable Opinion