REDUCER-I: An Observational Study of the Neovasc Reducer™ System
NCT ID: NCT02710435
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
400 participants
OBSERVATIONAL
2016-03-31
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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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
Reducer System
An aid in the management of chronic refractory angina pectoris
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
Reducer System
An aid in the management of chronic refractory angina pectoris
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
Reducer System
An aid in the management of chronic refractory angina pectoris
Interventions
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Reducer System
An aid in the management of chronic refractory angina pectoris
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Shockwave Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stefan Verheye, MD
Role: PRINCIPAL_INVESTIGATOR
ZNA Middelheim Hospital
Locations
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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
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
Hospital Clinico San Carlos
Madrid, , Spain
University Hospital Basel
Basel, , Switzerland
HFR Fribourg/University of Fribourg
Fribourg, , Switzerland
Hopitaux Universitaires Geneve (HUG)
Geneva, , Switzerland
Istituto Cardiocentro Ticino
Lugano, , Switzerland
Bradford Royal Infirmary
Bradford, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
St. Thomas Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Countries
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References
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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.
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.
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.
Related Links
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Company product webpage
Other Identifiers
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022-REDUCLN-001
Identifier Type: -
Identifier Source: org_study_id
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