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Open Access Study protocol

A phase II, sham-controlled, double-blinded study testing the safety and efficacy of the coronary sinus reducer in patients with refractory angina: study protocol for a randomized controlled trial

E Marc Jolicœur1*, Shmuel Banai2, Timothy D Henry3, Marc Schwartz4, Serge Doucet1, Christopher J White5, Elazer Edelman67 and Stefan Verheye8

Author Affiliations

1 Montreal Heart Institute, Université de Montréal, 5000 Bélanger Street East, Montréal, Québec Q H1T 1C8, Canada

2 The Tel Aviv Medical Center, The Tel Aviv University Medical School, 6 Weizman Street, Tel Aviv, 64239, Israel

3 Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, 920 East 28th Street, Minneapolis, MN, 55407, USA

4 Neovasc, Inc., 137000 Mayfield Place, Richmond, BC V6V 2E4, Canada

5 The John Ochsner Heart & Vascular Institute, Ochsner Clinical School, The University of Queensland School of Medicine, 1514 Jefferson Highway, New Orleans, LA, 70121, USA

6 Harvard-MIT Division of Health Sciences and Technology, 77 Massachusetts Avenue, Cambridge, MA, 02139, USA

7 Cardiovascular Division Brigham and Women’s Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA

8 Antwerp Cardiovascular Institute, ZNA Middelheim Hospital, Lindendreef 1, 2020, Antwerpen 22, Belgium

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Trials 2013, 14:46  doi:10.1186/1745-6215-14-46

Published: 15 February 2013

Abstract

Background

A growing population of patients lives with severe coronary artery disease not amenable to coronary revascularization and with refractory angina despite optimal medical therapy. Percutaneous reduction of the coronary sinus is an emerging treatment for myocardial ischemia that increases coronary sinus pressure to promote a transcollateral redistribution of coronary artery in-flow from nonischemic to ischemic subendocardial territories. A first-in-man study has demonstrated that the percutaneous reduction of the coronary sinus can be performed safely in such patients. The COSIRA trial seeks to assess whether a percutaneous reduction of the coronary sinus can improve the symptoms of refractory angina in patients with limited revascularization options.

Methods/Design

The COSIRA trial is a phase II double-blind, sham-controlled, randomized parallel trial comparing the percutaneously implanted coronary sinus Reducer (Neovasc Inc, Richmond, BC, Canada) to a sham implantation in 124 patients enrolled in Canada, Belgium, England, Scotland, Sweden and Denmark. All patients need to have stable Canadian Cardiovascular Society (CCS) class III or IV angina despite optimal medical therapy, with evidence of reversible ischemia related to disease in the left coronary artery, and a left ventricular ejection fraction >25%. Participants experiencing an improvement in their angina ≥2 CCS classes six months after the randomization will meet the primary efficacy endpoint. The secondary objective of this trial is to test whether coronary sinus Reducer implantation will improve left ventricular ischemia, as measured by the improvement in dobutamine echocardiogram wall motion score index and in time to 1 mm ST-segment depression from baseline to six-month post-implantation.

Discussion

Based on previous observations, the COSIRA is expected to provide a significant positive result or an informative null result upon which rational development decisions can be based. Patient safety is a central concern and extensive monitoring should allow an appropriate investigation of the safety related to the coronary sinus Reducer.

Trial registration

ClinicalTrials.gov identifier - NCT01205893.

Keywords:
Angina; Refractory angina; Advanced coronary artery disease; Myocardial ischemia; Coronary sinus; Reducer