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REDUCER-I: An Observational Study of the Neovasc Reducer™ System | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

REDUCER-I: An Observational Study of the Neovasc Reducer™ System

NCT02710435•Shockwave Medical, Inc.

Summary

The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.

Detailed Description

This study is a multicenter, multi-country three-arm prospective and retrospective investigation in up to 400 subjects conducted at a maximum of 40 investigational centers. Arm 1 will include eligible prospective subjects. Arm 2 will include subjects who were previously enrolled and treated with the Reducer during the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) study. Arm 3 will include subjects who received a Reducer under CE Mark (unrelated to the COSIRA study).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has been informed about the study and provides written informed consent prior to enrollment
•Subject is willing to comply with specified follow-up evaluations
•Symptomatic Coronary Artery Disease (CAD) with chronic refractory angina pectoris despite attempted optimal medical therapy
•Subject has limited treatment options for revascularization by Coronary Artery Bypass Grafting (CABG) or by Percutaneous Coronary Intervention (PCI)
•Evidence of reversible myocardial ischemia
•Left Ventricular ejection fraction (LVEF) greater than or equal to 30%
•Male or non-pregnant female
•Subjects previously implanted in the Reducer (treatment) arm of the COSIRA study
•Subjects in whom the Reducer was implanted under CE Mark (unrelated to the COSIRA study), prior to enrollment in the Reducer-I study

Exclusion Criteria

•Acute coronary syndrome within three months prior to enrollment
•Recent successful revascularization by PCI or CABG within six months prior to enrollment
•Recent unsuccessful PCI (no relief from symptoms) within 30 days prior to enrollment
•Unstable angina (recent onset angina, crescendo angina, or rest angina with electrocardiogram \[ECG\] changes) during the 30 days prior to enrollment
•Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to enrollment
•Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second that is less than 55% of the predicted value
•Subject cannot undergo exercise tolerance test
•Subject cannot undergo 6-minute walk test
•Severe valvular heart disease
•Subject with pacemaker electrode in the coronary sinus (CS)
+12 more criteria

Locations (25)

University of Graz

Graz, Austria

ZNA Middelheim Hospital

Antwerp, Belgium

Zienkenhuis Oost-Limburg

Genk, Belgium

University Hospital of Brest

Brest, France

Institut Coeur Poumon

Lille, France

Kerckhoff Klinik

Bad Nauheim, Germany

Dresden University

Dresden, Germany

Contilia Heart and Vascular Centre, Elisabeth Krankenhaus Essen, Klinik fϋr Kardiologie und Angiologie

Essen, Germany

University Heart Center Freiburg - Bad Krozingen

Freiburg im Breisgau, Germany

University Giessen

Giessen, Germany

Key Dates

Start Date

March 1, 2016

Primary Completion Date

November 1, 2023

Completion Date

December 1, 2028

Last Updated

November 18, 2025

Enrollment

400

ESTIMATED participants

Conditions

Angina PectorisAngina Pectoris, StableChronic Stable Angina

Interventions

Reducer System

DEVICE

Aerobic Exercise-induced Effect on Endothelial Function in Patients With Ischaemic Heart Disease

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RECRUITINGPHASE4

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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REDUCER-I: An Observational Study of the Neovasc Reducer™ System

Inclusion Criteria

Exclusion Criteria

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