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The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reducer System | Device | An aid in the management of chronic refractory angina pectoris |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 12 months and annually through 5 years post implant as compared to baseline | 12 months and annually through 5 years |
| Occurrence of Major Adverse Cardiac Events (MACE) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Exercise Tolerance Test (ETT) Parameters | 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 | 6 and 12 months |
| Improvement in Quality of Life (QoL |
Inclusion Criteria - ALL Arms:
Inclusion Criteria - Arm 1:
Inclusion Criteria - Arm 2:
Inclusion Criteria - Arm 3:
Exclusion Criteria - Arm 1:
Angiographic Exclusion:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Verheye, MD | ZNA Middelheim Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Graz | Graz | 8010 | Austria | |||
| ZNA Middelheim Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17466229 | Background | 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. | |
| 25970058 |
| Label | URL |
|---|---|
| Company product webpage | View source |
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|
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 |
| 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 |
| 6 months, 12 months, and annually through 5 years |
| Reduction in Emergency Department Visits | 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 | 12 months |
| Reduction in Angina Medication | Reduction in angina medication use at 6 months, 12 months and annually through 5 years post implant as compared to baseline | 6 months, 12 months, and annually through 5 years |
| Antwerp |
| 2020 |
| Belgium |
| Zienkenhuis Oost-Limburg | Genk | 3600 | Belgium |
| University Hospital of Brest | Brest | France |
| Institut Coeur Poumon | Lille | France |
| Kerckhoff Klinik | Bad Nauheim | 61231 | Germany |
| Dresden University | Dresden | 01307 | Germany |
| Contilia Heart and Vascular Centre, Elisabeth Krankenhaus Essen, Klinik fϋr Kardiologie und Angiologie | Essen | 45138 | Germany |
| University Heart Center Freiburg - Bad Krozingen | Freiburg im Breisgau | 79106 | Germany |
| University Giessen | Giessen | 35392 | Germany |
| University Heart Center Hamburg | Hamburg | 20246 | Germany |
| San Raffaele Hospital | Milan | 20132 | Italy |
| Bolognini General Hospital | Seriate | 24068 | Italy |
| St. Antonius Ziekenhuis | Nieuwegein | 3435CM | Netherlands |
| UMC Utrecht | Utrecht | 3584 CX | Netherlands |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| University Hospital Basel | Basel | CH-4031 | Switzerland |
| HFR Fribourg/University of Fribourg | Fribourg | 1708 | Switzerland |
| Hopitaux Universitaires Geneve (HUG) | Geneva | 1205 | Switzerland |
| Istituto Cardiocentro Ticino | Lugano | 6900 | Switzerland |
| Bradford Royal Infirmary | Bradford | BD9 6RJ | United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| St. Thomas Hospital | London | SE1 7EH | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| 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. |
| 25651246 | 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. |
| 26886464 | 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. |
| 27299456 | 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. |
| 24561732 | 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. |
| 33319762 | 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. |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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