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

NCT02710435 | Active Not Recruiting

• 1 other identifier: 022-REDUCLN-001
• Study Type: observational
• Target: 400
• Locations: 9 countries
• Sites: 25

Brief Summary

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

Conditions

Angina Pectoris; Angina Pectoris, Stable; Chronic Stable Angina

Keywords

Coronary Sinus; Reducer; Refractory Angina; Angina Pectoris; Angina Pectoris, Stable; Chronic Stable Angina; 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Reduction in Canadian Cardiovascular Society (CCS) Grade

  12 months and annually through 5 years

• Occurrence of Major Adverse Cardiac Events (MACE)

  6 months, 12 months, and annually through 5 years

Other Outcomes (4)

• Change in Exercise Tolerance Test (ETT) Parameters

  6 and 12 months

• Improvement in Quality of Life (QoL

  6 months, 12 months, and annually through 5 years

• Reduction in Emergency Department Visits

  12 months

Study Arms (3)

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

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

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

Interventions

Reducer System DEVICE

An aid in the management of chronic refractory angina pectoris

Also known as: Reducer

Arm 1 - Prospective; Arm 2 - COSIRA; Arm 3 - CE Mark

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead

Study Sites (25)

University of Graz

Graz, 8010, Austria

Location

ZNA Middelheim Hospital

Antwerp, 2020, Belgium

Location

Zienkenhuis Oost-Limburg

Genk, 3600, Belgium

Location

University Hospital of Brest

Brest, France

Location

Institut Coeur Poumon

Lille, France

Location

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

Location

Dresden University

Dresden, 01307, Germany

Location

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

Essen, 45138, Germany

Location

University Heart Center Freiburg - Bad Krozingen

Freiburg im Breisgau, 79106, Germany

Location

University Giessen

Giessen, 35392, Germany

Location

University Heart Center Hamburg

Hamburg, 20246, Germany

Location

San Raffaele Hospital

Milan, 20132, Italy

Location

Bolognini General Hospital

Seriate, 24068, Italy

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435CM, Netherlands

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

University Hospital Basel

Basel, CH-4031, Switzerland

Location

HFR Fribourg/University of Fribourg

Fribourg, 1708, Switzerland

Location

Hopitaux Universitaires Geneve (HUG)

Geneva, 1205, Switzerland

Location

Istituto Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

St. Thomas Hospital

London, SE1 7EH, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 17466229 BACKGROUND

• 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.

  PMID: 25970058 BACKGROUND

• 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.

  PMID: 25651246 BACKGROUND

• 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.

  PMID: 26886464 BACKGROUND

• 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.

  PMID: 27299456 BACKGROUND

• 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.

  PMID: 24561732 BACKGROUND

• 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.

  PMID: 33319762 BACKGROUND

Related Links

• Company product webpage

MeSH Terms

Conditions

Angina Pectoris; Angina, Stable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Verheye, MD

  ZNA Middelheim Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 16, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2023
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); NL (2); CH (4); AU (1); ES (1); BE (2); GB (5); DE (6); FR (2)