An Observational Study of the Neovasc Reducerâ„¢ System (2024)

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).

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~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

Source: Neovasc Inc.

StartDate: 2016-03-31

Date Last Changed:

Has Expanded Access? f

Sponsors

lead: Neovasc Inc.

collaborator: Shockwave Medical, Inc.

References

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.

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.

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.

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.

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.

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.

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.

Trial Status & Requirements

Facilities

Conditions:

Angina Pectoris
Angina Pectoris, Stable
Chronic Stable Angina