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

Active, not recruiting

• Conditions: Chronic Stable Angina; Angina Pectoris; Angina Pectoris, Stable
• Interventions: Device: Reducer System

• Registration Number: NCT02710435
• Lead Sponsor: Neovasc Inc.

Brief 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).

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-16
• Primary Completion: 2023-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 3 - CE Mark	Reducer System	Includes subjects who received a Reducer System under CE Mark (unrelated to the COSIRA study), and agree to participate in this long term follow up study Arm 3 has been closed to enrollment-June 2017
Arm 1 - Prospective	Reducer System	Includes eligible subjects in the prospective arm who undergo baseline testing followed by the Reducer System implant procedure Arm 1 has been closed to enrollment-March 2023
Arm 2 - COSIRA	Reducer System	Includes subjects who were previously enrolled and treated with the Reducer System during the COSIRA study and agree to participate in this long term follow up study

Primary Outcome Measures

Name	Time	Method
Reduction in Canadian Cardiovascular Society (CCS) Grade	6 Months	The percentage of subjects who experience improvement in their angina symptoms defined as a reduction in CCS grade, at 6 months as compared to baseline
Rate of Occurrence of Device and/or Procedure Related Peri-Procedural Serious Adverse Events (SAE)s	30 days post implant	The rate of occurrence of device and / or procedure-related periprocedural SAEs defined as a composite of death, Myocardial Infarction (MI), cardiac tamponade, clinically-driven re-dilation of a Reducer, life-threatening arrhythmias (Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF)), and respiratory failure through 30 days post-implant
Occurrence of Major Adverse Cardiac Events (MACE)	30 days post implant	Major Adverse Cardiac Events (MACE): a composite of cardiac death, major stroke, and MI through 30-days post-implant

Secondary Outcome Measures

Name	Time	Method
Reduction in Canadian Cardiovascular Society (CCS) Grade	12 months and annually through 5 years	The percentage of subjects who experience improvement in their angina symptoms defined as a reduction in CCS grade at 12 months and annually through 5 years post implant as compared to baseline
Occurrence of Major Adverse Cardiac Events (MACE)	6 months, 12 months, and annually through 5 years	Major Adverse Cardiac Events (MACE): a composite of cardiac death, major stroke, and MI at 6 months, 12 months and annually through 5 years post implant

Trial Locations

Locations (25)

ZNA Middelheim Hospital; 🇧🇪 Antwerpen, Belgium

Zienkenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

University Hospital of Brest; 🇫🇷 Brest, France

Kerckhoff Klinik; 🇩🇪 Bad Nauheim, Germany

Institut Coeur Poumon; 🇫🇷 Lille, France

Dresden University; 🇩🇪 Dresden, Germany

University Heart Center Freiburg - Bad Krozingen; 🇩🇪 Freiburg, Germany

Contilia Heart and Vascular Centre, Elisabeth Krankenhaus Essen, Klinik fϋr Kardiologie und Angiologie; 🇩🇪 Essen, Germany

University Giessen; 🇩🇪 Giessen, Germany

University Heart Center Hamburg; 🇩🇪 Hamburg, Germany

San Raffaele Hospital; 🇮🇹 Milan, Italy

Bolognini General Hospital; 🇮🇹 Seriate, Italy

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

University Hospital Basel; 🇨🇭 Basel, Switzerland

HFR Fribourg/University of Fribourg; 🇨🇭 Fribourg, Switzerland

Istituto Cardiocentro Ticino; 🇨🇭 Lugano, Switzerland

Hopitaux Universitaires Geneve (HUG); 🇨🇭 Geneva, Switzerland

Bradford Royal Infirmary; 🇬🇧 Bradford, United Kingdom

St. Thomas Hospital; 🇬🇧 London, United Kingdom

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

King's College Hospital; 🇬🇧 London, United Kingdom

University of Graz; 🇦🇹 Graz, Austria

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Royal Brompton Hospital; 🇬🇧 London, United Kingdom