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

Active, not recruiting

• Conditions: Chronic Stable Angina; Angina Pectoris; Angina Pectoris, Stable

• 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

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)

University of Graz; 🇦🇹 Graz, Austria

ZNA Middelheim Hospital; 🇧🇪 Antwerpen, 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, Germany

University Giessen; 🇩🇪 Giessen, Germany

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