REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Study Details
Study Description
Brief Summary
The purpose of this study is to collect long term data of the Neovasc Reducer System in subjects with refractory angina pectoris.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Arm 1 - Prospective Includes eligible subjects in the prospective arm who undergo baseline testing followed by the Neovasc Reducer System implant procedure |
Device: Neovasc Reducer System
An aid in the management of chronic refractory angina pectoris
Other Names:
|
| Arm 2 - COSIRA Includes subjects who were previously enrolled and treated with the Neovasc Reducer System during the COSIRA study and agree to participate in this long term follow up study |
Device: Neovasc Reducer System
An aid in the management of chronic refractory angina pectoris
Other Names:
|
| Arm 3 - CE Mark Includes subjects who received a Neovasc 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: Neovasc Reducer System
An aid in the management of chronic refractory angina pectoris
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
Secondary Outcome Measures
- Reduction in Canadian Cardiovascular Society (CCS) Grade [12 months and annually through 5 years]
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
- Occurrence of Major Adverse Cardiac Events (MACE) [6 months, 12 months, and annually through 5 years]
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
Other Outcome Measures
- Change in Exercise Tolerance Test (ETT) Parameters [6 and 12 months]
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
- Improvement in Quality of Life (QoL [6 months, 12 months, and annually through 5 years]
Improvement in QoL scores at 6 months, 12 months and annually through 5 years post implant as compared to baseline
- Reduction in Emergency Department Visits [12 months]
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
- Reduction in Angina Medication [6 months, 12 months, and annually through 5 years]
Reduction in angina medication use at 6 months, 12 months and annually through 5 years post implant as compared to baseline
Eligibility Criteria
Criteria
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
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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
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Recent successful revascularization by PCI or CABG within six months prior to enrollment
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Recent unsuccessful PCI (no relief from symptoms) within 30 days prior to enrollment
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Unstable angina (recent onset angina, crescendo angina, or rest angina with electrocardiogram [ECG] changes) during the 30 days prior to enrollment
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Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to enrollment
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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
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Subject cannot undergo exercise tolerance test
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Subject cannot undergo 6-minute walk test
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Severe valvular heart disease
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Subject with pacemaker electrode in the coronary sinus (CS)
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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
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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
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Known severe reaction to required procedural medications
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Known allergy to stainless steel or nickel
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Magnetic Resonance Imaging (MRI) planned within 8 weeks after Reducer implantation
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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:
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Mean right atrial pressure greater than 15mmHg
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Subject with anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava [SVC])
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CS diameter at the site of planned Reducer implantation less than 9.5 mm or greater than 13 mm
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Graz | Graz | Austria | 8010 | |
| 2 | ZNA Middelheim Hospital | Antwerpen | Belgium | 2020 | |
| 3 | Zienkenhuis Oost-Limburg | Genk | Belgium | 3600 | |
| 4 | Kerckhoff Klinik | Bad Nauheim | Germany | 61231 | |
| 5 | Dresden University | Dresden | Germany | 01307 | |
| 6 | Contilia Heart and Vascular Centre, Elisabeth Krankenhaus Essen, Klinik fϋr Kardiologie und Angiologie | Essen | Germany | 45138 | |
| 7 | University Heart Center Freiburg - Bad Krozingen | Freiburg | Germany | 79106 | |
| 8 | University Giessen | Giessen | Germany | 35392 | |
| 9 | University Heart Center Hamburg | Hamburg | Germany | 20246 | |
| 10 | Krankenhaus Landshut Achdorf | Landshut | Germany | 84036 | |
| 11 | Lukaskrankenhaus Neuss | Neuss | Germany | 41464 | |
| 12 | Schwarzwald-Baar Klinikum Villingen-Schwenningen | Villingen-Schwenningen | Germany | 78050 | |
| 13 | San Raffaele Hospital | Milan | Italy | 20132 | |
| 14 | Bolognini General Hospital | Seriate | Italy | 24068 | |
| 15 | St. Antonius Ziekenhuis | Nieuwegein | Netherlands | 3435CM | |
| 16 | UMC Utrecht | Utrecht | Netherlands | 3584 CX | |
| 17 | Hospital Clinico San Carlos | Madrid | Spain | 28040 | |
| 18 | University Hospital Basel | Basel | Switzerland | CH-4031 | |
| 19 | HFR Fribourg/University of Fribourg | Fribourg | Switzerland | 1708 | |
| 20 | Hopitaux Universitaires Geneve (HUG) | Geneva | Switzerland | 1205 | |
| 21 | Istituto Cardiocentro Ticino | Lugano | Switzerland | 6900 | |
| 22 | Bradford Royal Infirmary | Bradford | United Kingdom | BD9 6RJ | |
| 23 | Royal Infirmary of Edinburgh | Edinburgh | United Kingdom | EH16 4SA | |
| 24 | St. Thomas Hospital | London | United Kingdom | SE1 7EH | |
| 25 | King's College Hospital | London | United Kingdom | SE5 9RS | |
| 26 | Royal Brompton Hospital | London | United Kingdom | SW3 6NP |
Sponsors and Collaborators
- Neovasc Inc.
Investigators
- Principal Investigator: Stefan Verheye, MD, ZNA Middelheim Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
- Konigstein M, Verheye S, Jolicœur 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. Review.
- 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.
- Verheye S, Jolicœur 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.
- 022-REDUCLN-001