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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Angina Pectoris; Chronic Stable Angina; Angina Pectoris, Stable
• Intervention / Treatment: Device: Reducer System

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • University of Graz
• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim Hospital
  • Genk, Belgium, 3600
    • Zienkenhuis Oost-Limburg
• France
  • Brest, France
    • University Hospital of Brest
  • Lille, France
    • Institut Coeur Poumon
• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff Klinik
  • Dresden, Germany, 01307
    • Dresden University
  • Essen, Germany, 45138
    • Contilia Heart and Vascular Centre, Elisabeth Krankenhaus Essen, Klinik fϋr Kardiologie und Angiologie
  • Freiburg im Breisgau, Germany, 79106
    • University Heart Center Freiburg - Bad Krozingen
  • Giessen, Germany, 35392
    • University Giessen
  • Hamburg, Germany, 20246
    • University Heart Center Hamburg
• Italy
  • Milan, Italy, 20132
    • San Raffaele Hospital
  • Seriate, Italy, 24068
    • Bolognini General Hospital
• Netherlands
  • Nieuwegein, Netherlands, 3435CM
    • St. Antonius Ziekenhuis
  • Utrecht, Netherlands, 3584 CX
    • UMC Utrecht
• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
• Switzerland
  • Basel, Switzerland, CH-4031
    • University Hospital Basel
  • Fribourg, Switzerland, 1708
    • HFR Fribourg/University of Fribourg
  • Geneva, Switzerland, 1205
    • Hopitaux Universitaires Geneve (HUG)
  • Lugano, Switzerland, 6900
    • Istituto Cardiocentro Ticino
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • Bradford Royal Infirmary
  • Edinburgh, United Kingdom, EH16 4SA
    • Royal Infirmary of Edinburgh
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
  • London, United Kingdom, SE1 7EH
    • St. Thomas Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with refractory angina pectoris who demonstrate objective evidence of reversible myocardial ischemia, who have limited or no options for revascularization, or subjects who have received the Reducer in the COSIRA study, or under CE Mark prior to the REDUCER-I study.

Description

Inclusion Criteria - ALL Arms:

• 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

Inclusion Criteria - Arm 1:

• 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

Inclusion Criteria - Arm 2:

• Subjects previously implanted in the Reducer (treatment) arm of the COSIRA study

Inclusion Criteria - Arm 3:

• 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 - Arm 1:

• 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)
• Subject with recent placement of a new pacemaker or defibrillator electrode in the right atrium within 3 months prior to enrollment.
• Subject having undergone tricuspid valve replacement or repair
• Chronic renal failure (serum creatinine >2 mg/dL), including subjects on chronic hemodialysis
• Moribund subjects, or subjects with comorbidities limiting life expectancy to less than one year
• Known severe reaction to required procedural medications
• Known allergy to stainless steel or nickel
• Magnetic Resonance Imaging (MRI) planned within 8 weeks after Reducer implantation
• Currently enrolled in another device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints

Angiographic Exclusion:

• Mean right atrial pressure greater than 15mmHg
• Subject with anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava [SVC])
• CS diameter at the site of planned Reducer implantation less than 9.5 mm or greater than 13 mm

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm 1 - Prospective; 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	Device: Reducer System; An aid in the management of chronic refractory angina pectoris; Other Names: Reducer
Arm 2 - COSIRA; 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	Device: Reducer System; An aid in the management of chronic refractory angina pectoris; Other Names: Reducer
Arm 3 - CE Mark; 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	Device: Reducer System; An aid in the management of chronic refractory angina pectoris; Other Names: Reducer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Canadian Cardiovascular Society (CCS) Grade	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	6 Months
Rate of Occurrence of Device and/or Procedure Related Peri-Procedural Serious Adverse Events (SAE)s	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	30 days post implant
Occurrence of Major Adverse Cardiac Events (MACE)	Major Adverse Cardiac Events (MACE): a composite of cardiac death, major stroke, and MI through 30-days post-implant	30 days post implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Canadian Cardiovascular Society (CCS) Grade	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	12 months and annually through 5 years
Occurrence of Major Adverse Cardiac Events (MACE)	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	6 months, 12 months, and annually through 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Exercise Tolerance Test (ETT) Parameters	The change in ETT parameters at 6 and 12 months post implant as compared to baseline: Total exercise duration (min), Time to 1mm ST-Segment Depression (min), METs, Double Product by ETT	6 and 12 months
Improvement in Quality of Life (QoL	Improvement in QoL scores at 6 months, 12 months and annually through 5 years post implant as compared to baseline	6 months, 12 months, and annually through 5 years
Reduction in Emergency Department Visits	Reduction in documented Emergency Department visits due to angina episodes at 12 months post implant as compared to 12 months prior to implantation of the Reducer	12 months
Reduction in Angina Medication	Reduction in angina medication use at 6 months, 12 months and annually through 5 years post implant as compared to baseline	6 months, 12 months, and annually through 5 years

Collaborators and Investigators

• Sponsor: Shockwave Medical, Inc.
• Collaborators: Shockwave Medical, Inc.
• Investigators: Principal Investigator: Stefan Verheye, MD, ZNA Middelheim Hospital

Publications and helpful links

General Publications

• Verheye S, Jolicoeur EM, Behan MW, Pettersson T, Sainsbury P, Hill J, Vrolix M, Agostoni P, Engstrom T, Labinaz M, de Silva R, Schwartz M, Meyten N, Uren NG, Doucet S, Tanguay JF, Lindsay S, Henry TD, White CJ, Edelman ER, Banai S. Efficacy of a device to narrow the coronary sinus in refractory angina. N Engl J Med. 2015 Feb 5;372(6):519-27. doi: 10.1056/NEJMoa1402556.
• Banai S, Ben Muvhar S, Parikh KH, Medina A, Sievert H, Seth A, Tsehori J, Paz Y, Sheinfeld A, Keren G. Coronary sinus reducer stent for the treatment of chronic refractory angina pectoris: a prospective, open-label, multicenter, safety feasibility first-in-man study. J Am Coll Cardiol. 2007 May 1;49(17):1783-9. doi: 10.1016/j.jacc.2007.01.061.
• Banai S, Verheye S, Jolicoeur EM. A device to narrow the coronary sinus for angina. N Engl J Med. 2015 May 14;372(20):1967-8. doi: 10.1056/NEJMc1503672. No abstract available.
• Konigstein M, Verheye S, Jolicoeur EM, Banai S. Narrowing of the Coronary Sinus: A Device-Based Therapy for Persistent Angina Pectoris. Cardiol Rev. 2016 Sep-Oct;24(5):238-43. doi: 10.1097/CRD.0000000000000101.
• Abawi M, Nijhoff F, Stella PR, Voskuil M, Benedetto D, Doevendans PA, Agostoni P. Safety and efficacy of a device to narrow the coronary sinus for the treatment of refractory angina: A single-centre real-world experience. Neth Heart J. 2016 Sep;24(9):544-51. doi: 10.1007/s12471-016-0862-2.
• Konigstein M, Meyten N, Verheye S, Schwartz M, Banai S. Transcatheter treatment for refractory angina with the Coronary Sinus Reducer. EuroIntervention. 2014 Feb;9(10):1158-64. doi: 10.4244/EIJV9I10A196.
• Verheye S, Agostoni P, Giannini F, Hill JM, Jensen C, Lindsay S, Stella PR, Redwood S, Banai S, Konigstein M. Coronary sinus narrowing for the treatment of refractory angina: a multicentre prospective open-label clinical study (the REDUCER-I study). EuroIntervention. 2021 Sep 20;17(7):561-568. doi: 10.4244/EIJ-D-20-00873.

Helpful Links

• Company product webpage

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): November 1, 2023
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (Estimated): March 16, 2016

Study Record Updates

• Last Update Posted (Actual): July 30, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Refractory Angina; Angina Pectoris; Chronic Stable Angina; Coronary Sinus; Reducer; Angina Pectoris, Stable; Persistent Angina; Neovasc Reducer System; Refractory Angina Pectoris; Coronary Sinus Narrowing; Reversible Ischemic Heart Disease; Chronic Angina; End Stage Angina; Coronary Sinus Reduction; Coronary Sinus Reducer; Chronic Refractory Angina; Chronic Refractory Angina Pectoris
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Chest Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: 022-REDUCLN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO