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Active, not recruiting Observational

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

NCT02710435 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2016-03
Last updated
2026-07-30

Condition(s) studied

Angina PectorisAngina Pectoris, StableChronic Stable Angina

Investigational drug(s) / intervention(s)

Reducer System

Reducer System: An aid in the management of chronic refractory angina pectoris

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (25)

FacilityCityRegionStatus
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

More Shockwave Medical, Inc. trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02710435 on ClinicalTrials.gov ↗ ← All trials in Spain