REDUCER-I
Research type
Research Study
Full title
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
IRAS ID
190140
Sponsor organisation
Neovasc Inc.
Clinicaltrials.gov Identifier
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