Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-01-05 @ 6:54 PM
Study NCT ID:
NCT02710435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2016-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2016-03-11', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Exercise Tolerance Test (ETT) Parameters', 'timeFrame': '6 and 12 months', 'description': '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'}, {'measure': 'Improvement in Quality of Life (QoL', 'timeFrame': '6 months, 12 months, and annually through 5 years', 'description': 'Improvement in QoL scores at 6 months, 12 months and annually through 5 years post implant as compared to baseline'}, {'measure': 'Reduction in Emergency Department Visits', 'timeFrame': '12 months', 'description': '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'}, {'measure': 'Reduction in Angina Medication', 'timeFrame': '6 months, 12 months, and annually through 5 years', 'description': 'Reduction in angina medication use at 6 months, 12 months and annually through 5 years post implant as compared to baseline'}], 'primaryOutcomes': [{'measure': 'Reduction in Canadian Cardiovascular Society (CCS) Grade', 'timeFrame': '6 Months', 'description': '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'}, {'measure': 'Rate of Occurrence of Device and/or Procedure Related Peri-Procedural Serious Adverse Events (SAE)s', 'timeFrame': '30 days post implant', 'description': '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'}, {'measure': 'Occurrence of Major Adverse Cardiac Events (MACE)', 'timeFrame': '30 days post implant', 'description': 'Major Adverse Cardiac Events (MACE): a composite of cardiac death, major stroke, and MI through 30-days post-implant'}], 'secondaryOutcomes': [{'measure': 'Reduction in Canadian Cardiovascular Society (CCS) Grade', 'timeFrame': '12 months and annually through 5 years', 'description': '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'}, {'measure': 'Occurrence of Major Adverse Cardiac Events (MACE)', 'timeFrame': '6 months, 12 months, and annually through 5 years', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary Sinus', 'Reducer', 'Refractory Angina', 'Angina Pectoris', 'Angina Pectoris, Stable', 'Chronic Stable Angina', 'Persistent Angina', 'Neovasc Reducer System', 'Refractory Angina Pectoris', 'Coronary Sinus Narrowing', 'Reversible Ischemic Heart Disease', 'Chronic Angina', 'End Stage Angina', 'Coronary Sinus Reduction', 'Coronary Sinus Reducer', 'Chronic Refractory Angina', 'Chronic Refractory Angina Pectoris'], 'conditions': ['Angina Pectoris', 'Angina Pectoris, Stable', 'Chronic Stable Angina']}, 'referencesModule': {'references': [{'pmid': '17466229', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25970058', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25651246', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26886464', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27299456', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24561732', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33319762', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://shockwavemedical.com/clinicians/international/coronary/coronary-sinus-reduction/', 'label': 'Company product webpage'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria - ALL Arms:\n\n* Subject has been informed about the study and provides written informed consent prior to enrollment\n* Subject is willing to comply with specified follow-up evaluations\n\nInclusion Criteria - Arm 1:\n\n* Symptomatic Coronary Artery Disease (CAD) with chronic refractory angina pectoris despite attempted optimal medical therapy\n* Subject has limited treatment options for revascularization by Coronary Artery Bypass Grafting (CABG) or by Percutaneous Coronary Intervention (PCI)\n* Evidence of reversible myocardial ischemia\n* Left Ventricular ejection fraction (LVEF) greater than or equal to 30%\n* Male or non-pregnant female\n\nInclusion Criteria - Arm 2:\n\n* Subjects previously implanted in the Reducer (treatment) arm of the COSIRA study\n\nInclusion Criteria - Arm 3:\n\n* Subjects in whom the Reducer was implanted under CE Mark (unrelated to the COSIRA study), prior to enrollment in the Reducer-I study\n\nExclusion Criteria - Arm 1:\n\n* Acute coronary syndrome within three months prior to enrollment\n* Recent successful revascularization by PCI or CABG within six months prior to enrollment\n* Recent unsuccessful PCI (no relief from symptoms) within 30 days prior to enrollment\n* Unstable angina (recent onset angina, crescendo angina, or rest angina with electrocardiogram \\[ECG\\] changes) during the 30 days prior to enrollment\n* Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to enrollment\n* 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\n* Subject cannot undergo exercise tolerance test\n* Subject cannot undergo 6-minute walk test\n* Severe valvular heart disease\n* Subject with pacemaker electrode in the coronary sinus (CS)\n* Subject with recent placement of a new pacemaker or defibrillator electrode in the right atrium within 3 months prior to enrollment.\n* Subject having undergone tricuspid valve replacement or repair\n* Chronic renal failure (serum creatinine \\>2 mg/dL), including subjects on chronic hemodialysis\n* Moribund subjects, or subjects with comorbidities limiting life expectancy to less than one year\n* Known severe reaction to required procedural medications\n* Known allergy to stainless steel or nickel\n* Magnetic Resonance Imaging (MRI) planned within 8 weeks after Reducer implantation\n* Currently enrolled in another device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints\n\nAngiographic Exclusion:\n\n* Mean right atrial pressure greater than 15mmHg\n* Subject with anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava \\[SVC\\])\n* CS diameter at the site of planned Reducer implantation less than 9.5 mm or greater than 13 mm'}, 'identificationModule': {'nctId': 'NCT02710435', 'briefTitle': 'REDUCER-I: An Observational Study of the Neovasc Reducer™ System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shockwave Medical, Inc.'}, 'officialTitle': 'REDUCER-I: An Observational Study of the Neovasc Reducer™ System', 'orgStudyIdInfo': {'id': '022-REDUCLN-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1 - Prospective', 'description': 'Includes eligible subjects in the prospective arm who undergo baseline testing followed by the Reducer System implant procedure\n\nArm 1 has been closed to enrollment-March 2023', 'interventionNames': ['Device: Reducer System']}, {'label': 'Arm 2 - COSIRA', 'description': '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', 'interventionNames': ['Device: Reducer System']}, {'label': 'Arm 3 - CE Mark', 'description': '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\n\nArm 3 has been closed to enrollment-June 2017', 'interventionNames': ['Device: Reducer System']}], 'interventions': [{'name': 'Reducer System', 'type': 'DEVICE', 'otherNames': ['Reducer'], 'description': 'An aid in the management of chronic refractory angina pectoris', 'armGroupLabels': ['Arm 1 - Prospective', 'Arm 2 - COSIRA', 'Arm 3 - CE Mark']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'country': 'Austria', 'facility': 'University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Middelheim Hospital', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '3600', 'city': 'Genk', 'country': 'Belgium', 'facility': 'Zienkenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Brest', 'country': 'France', 'facility': 'University Hospital of Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Lille', 'country': 'France', 'facility': 'Institut Coeur Poumon', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff Klinik', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Dresden University', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '45138', 'city': 'Essen', 'country': 'Germany', 'facility': 'Contilia Heart and Vascular Centre, Elisabeth Krankenhaus Essen, Klinik fϋr Kardiologie und Angiologie', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'University Heart Center Freiburg - Bad Krozingen', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'University Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Heart Center Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'San Raffaele Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '24068', 'city': 'Seriate', 'country': 'Italy', 'facility': 'Bolognini General Hospital', 'geoPoint': {'lat': 45.68532, 'lon': 9.72487}}, {'zip': '3435CM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'CH-4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '1708', 'city': 'Fribourg', 'country': 'Switzerland', 'facility': 'HFR Fribourg/University of Fribourg', 'geoPoint': {'lat': 46.80237, 'lon': 7.15128}}, {'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hopitaux Universitaires Geneve (HUG)', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '6900', 'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Istituto Cardiocentro Ticino', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'zip': 'BD9 6RJ', 'city': 'Bradford', 'country': 'United Kingdom', 'facility': 'Bradford Royal Infirmary', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'zip': 'EH16 4SA', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'St. Thomas Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6NP', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Stefan Verheye, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ZNA Middelheim Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shockwave Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}