Clinical Trials in France / NCT02710435
Active, not recruiting
Observational
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
NCT02710435 · tracked via the Priya Life Science France tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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 France