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Gad Keren - One of the best experts on this subject based on the ideXlab platform.
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coronary sinus reducer stent for the treatment of chronic refractory angina pectoris a prospective open label multicenter safety feasibility first in man Study
Journal of the American College of Cardiology, 2007Co-Authors: Shmuel Banai, Shmuel Ben Muvhar, Keyur Parikh, Aharon Medina, Horst Sievert, Ashok Seth, Jonathan Tsehori, Yoav Paz, Ami Sheinfeld, Gad KerenAbstract:Objectives This Study sought to evaluate the safety of the Coronary Sinus Reducer (Neovasc Medical, Inc., Or Yehuda, Israel) as a potential alternate therapy for patients with refractory angina who are not candidates for conventional revascularization procedures. Background Increased coronary sinus (CS) pressure can reduce myocardial ischemia by redistribution of blood from nonischemic to ischemic territories. The Coronary Sinus Reducer is a percutaneous implantable device designed to establish CS narrowing and to elevate CS pressure. In preclinical experiments, implantation of the Reducer was safe and was associated with improved ischemic parameters. In the present Study, the safety and feasibility of the Coronary Sinus Reducer was evaluated in patients with refractory angina who were not candidates for revascularization. Methods Fifteen coronary artery disease patients with severe angina and reversible ischemia were electively treated with the Reducer. Clinical evaluation, dobutamine echocardiography, thallium single-photon emission computed tomography, and administration of an angina questionnaire were performed before and 6 months after implantation. Cardiac computed tomography was performed 2 days and 6 months after implantation. Results All procedures were completed successfully. No procedure-related adverse events occurred during the periprocedural and the follow-up periods. Angina score improved in 12 of 14 patients. Average Canadian Cardiovascular Society score was 3.07 at baseline and 1.64 at follow-up (n = 14, p Conclusions Implantation of the Coronary Sinus Reducer is feasible and safe. These findings, along with the clinical improvement observed, support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization.
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coronary sinus reducer stent for the treatment of chronic refractory angina pectoris a prospective open label multicenter safety feasibility first in man Study
Journal of the American College of Cardiology, 2007Co-Authors: Shmuel Banai, Shmuel Ben Muvhar, Keyur Parikh, Aharon Medina, Horst Sievert, Ashok Seth, Jonathan Tsehori, Yoav Paz, Ami Sheinfeld, Gad KerenAbstract:Coronary Sinus Reducer Stent for the Treatment of Chronic Refractory Angina Pectoris: A Prospective, Open Label, Multicenter Safety Feasibility First-in-Man StudyShmuel Banai, Shmuel Ben Muvhar, Ke...
Shmuel Banai - One of the best experts on this subject based on the ideXlab platform.
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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
Trials, 2013Co-Authors: Marc E Jolicœur, Shmuel Banai, Timothy D Henry, Marc Schwartz, Serge Doucet, Christopher J White, Elazer R Edelman, Stefan VerheyeAbstract: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.
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coronary sinus reducer stent for the treatment of chronic refractory angina pectoris a prospective open label multicenter safety feasibility first in man Study
Journal of the American College of Cardiology, 2007Co-Authors: Shmuel Banai, Shmuel Ben Muvhar, Keyur Parikh, Aharon Medina, Horst Sievert, Ashok Seth, Jonathan Tsehori, Yoav Paz, Ami Sheinfeld, Gad KerenAbstract:Objectives This Study sought to evaluate the safety of the Coronary Sinus Reducer (Neovasc Medical, Inc., Or Yehuda, Israel) as a potential alternate therapy for patients with refractory angina who are not candidates for conventional revascularization procedures. Background Increased coronary sinus (CS) pressure can reduce myocardial ischemia by redistribution of blood from nonischemic to ischemic territories. The Coronary Sinus Reducer is a percutaneous implantable device designed to establish CS narrowing and to elevate CS pressure. In preclinical experiments, implantation of the Reducer was safe and was associated with improved ischemic parameters. In the present Study, the safety and feasibility of the Coronary Sinus Reducer was evaluated in patients with refractory angina who were not candidates for revascularization. Methods Fifteen coronary artery disease patients with severe angina and reversible ischemia were electively treated with the Reducer. Clinical evaluation, dobutamine echocardiography, thallium single-photon emission computed tomography, and administration of an angina questionnaire were performed before and 6 months after implantation. Cardiac computed tomography was performed 2 days and 6 months after implantation. Results All procedures were completed successfully. No procedure-related adverse events occurred during the periprocedural and the follow-up periods. Angina score improved in 12 of 14 patients. Average Canadian Cardiovascular Society score was 3.07 at baseline and 1.64 at follow-up (n = 14, p Conclusions Implantation of the Coronary Sinus Reducer is feasible and safe. These findings, along with the clinical improvement observed, support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization.
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coronary sinus reducer stent for the treatment of chronic refractory angina pectoris a prospective open label multicenter safety feasibility first in man Study
Journal of the American College of Cardiology, 2007Co-Authors: Shmuel Banai, Shmuel Ben Muvhar, Keyur Parikh, Aharon Medina, Horst Sievert, Ashok Seth, Jonathan Tsehori, Yoav Paz, Ami Sheinfeld, Gad KerenAbstract:Coronary Sinus Reducer Stent for the Treatment of Chronic Refractory Angina Pectoris: A Prospective, Open Label, Multicenter Safety Feasibility First-in-Man StudyShmuel Banai, Shmuel Ben Muvhar, Ke...
Ami Sheinfeld - One of the best experts on this subject based on the ideXlab platform.
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coronary sinus reducer stent for the treatment of chronic refractory angina pectoris a prospective open label multicenter safety feasibility first in man Study
Journal of the American College of Cardiology, 2007Co-Authors: Shmuel Banai, Shmuel Ben Muvhar, Keyur Parikh, Aharon Medina, Horst Sievert, Ashok Seth, Jonathan Tsehori, Yoav Paz, Ami Sheinfeld, Gad KerenAbstract:Objectives This Study sought to evaluate the safety of the Coronary Sinus Reducer (Neovasc Medical, Inc., Or Yehuda, Israel) as a potential alternate therapy for patients with refractory angina who are not candidates for conventional revascularization procedures. Background Increased coronary sinus (CS) pressure can reduce myocardial ischemia by redistribution of blood from nonischemic to ischemic territories. The Coronary Sinus Reducer is a percutaneous implantable device designed to establish CS narrowing and to elevate CS pressure. In preclinical experiments, implantation of the Reducer was safe and was associated with improved ischemic parameters. In the present Study, the safety and feasibility of the Coronary Sinus Reducer was evaluated in patients with refractory angina who were not candidates for revascularization. Methods Fifteen coronary artery disease patients with severe angina and reversible ischemia were electively treated with the Reducer. Clinical evaluation, dobutamine echocardiography, thallium single-photon emission computed tomography, and administration of an angina questionnaire were performed before and 6 months after implantation. Cardiac computed tomography was performed 2 days and 6 months after implantation. Results All procedures were completed successfully. No procedure-related adverse events occurred during the periprocedural and the follow-up periods. Angina score improved in 12 of 14 patients. Average Canadian Cardiovascular Society score was 3.07 at baseline and 1.64 at follow-up (n = 14, p Conclusions Implantation of the Coronary Sinus Reducer is feasible and safe. These findings, along with the clinical improvement observed, support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization.
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coronary sinus reducer stent for the treatment of chronic refractory angina pectoris a prospective open label multicenter safety feasibility first in man Study
Journal of the American College of Cardiology, 2007Co-Authors: Shmuel Banai, Shmuel Ben Muvhar, Keyur Parikh, Aharon Medina, Horst Sievert, Ashok Seth, Jonathan Tsehori, Yoav Paz, Ami Sheinfeld, Gad KerenAbstract:Coronary Sinus Reducer Stent for the Treatment of Chronic Refractory Angina Pectoris: A Prospective, Open Label, Multicenter Safety Feasibility First-in-Man StudyShmuel Banai, Shmuel Ben Muvhar, Ke...
Yoav Paz - One of the best experts on this subject based on the ideXlab platform.
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coronary sinus reducer stent for the treatment of chronic refractory angina pectoris a prospective open label multicenter safety feasibility first in man Study
Journal of the American College of Cardiology, 2007Co-Authors: Shmuel Banai, Shmuel Ben Muvhar, Keyur Parikh, Aharon Medina, Horst Sievert, Ashok Seth, Jonathan Tsehori, Yoav Paz, Ami Sheinfeld, Gad KerenAbstract:Objectives This Study sought to evaluate the safety of the Coronary Sinus Reducer (Neovasc Medical, Inc., Or Yehuda, Israel) as a potential alternate therapy for patients with refractory angina who are not candidates for conventional revascularization procedures. Background Increased coronary sinus (CS) pressure can reduce myocardial ischemia by redistribution of blood from nonischemic to ischemic territories. The Coronary Sinus Reducer is a percutaneous implantable device designed to establish CS narrowing and to elevate CS pressure. In preclinical experiments, implantation of the Reducer was safe and was associated with improved ischemic parameters. In the present Study, the safety and feasibility of the Coronary Sinus Reducer was evaluated in patients with refractory angina who were not candidates for revascularization. Methods Fifteen coronary artery disease patients with severe angina and reversible ischemia were electively treated with the Reducer. Clinical evaluation, dobutamine echocardiography, thallium single-photon emission computed tomography, and administration of an angina questionnaire were performed before and 6 months after implantation. Cardiac computed tomography was performed 2 days and 6 months after implantation. Results All procedures were completed successfully. No procedure-related adverse events occurred during the periprocedural and the follow-up periods. Angina score improved in 12 of 14 patients. Average Canadian Cardiovascular Society score was 3.07 at baseline and 1.64 at follow-up (n = 14, p Conclusions Implantation of the Coronary Sinus Reducer is feasible and safe. These findings, along with the clinical improvement observed, support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization.
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coronary sinus reducer stent for the treatment of chronic refractory angina pectoris a prospective open label multicenter safety feasibility first in man Study
Journal of the American College of Cardiology, 2007Co-Authors: Shmuel Banai, Shmuel Ben Muvhar, Keyur Parikh, Aharon Medina, Horst Sievert, Ashok Seth, Jonathan Tsehori, Yoav Paz, Ami Sheinfeld, Gad KerenAbstract:Coronary Sinus Reducer Stent for the Treatment of Chronic Refractory Angina Pectoris: A Prospective, Open Label, Multicenter Safety Feasibility First-in-Man StudyShmuel Banai, Shmuel Ben Muvhar, Ke...
Jonathan Tsehori - One of the best experts on this subject based on the ideXlab platform.
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coronary sinus reducer stent for the treatment of chronic refractory angina pectoris a prospective open label multicenter safety feasibility first in man Study
Journal of the American College of Cardiology, 2007Co-Authors: Shmuel Banai, Shmuel Ben Muvhar, Keyur Parikh, Aharon Medina, Horst Sievert, Ashok Seth, Jonathan Tsehori, Yoav Paz, Ami Sheinfeld, Gad KerenAbstract:Objectives This Study sought to evaluate the safety of the Coronary Sinus Reducer (Neovasc Medical, Inc., Or Yehuda, Israel) as a potential alternate therapy for patients with refractory angina who are not candidates for conventional revascularization procedures. Background Increased coronary sinus (CS) pressure can reduce myocardial ischemia by redistribution of blood from nonischemic to ischemic territories. The Coronary Sinus Reducer is a percutaneous implantable device designed to establish CS narrowing and to elevate CS pressure. In preclinical experiments, implantation of the Reducer was safe and was associated with improved ischemic parameters. In the present Study, the safety and feasibility of the Coronary Sinus Reducer was evaluated in patients with refractory angina who were not candidates for revascularization. Methods Fifteen coronary artery disease patients with severe angina and reversible ischemia were electively treated with the Reducer. Clinical evaluation, dobutamine echocardiography, thallium single-photon emission computed tomography, and administration of an angina questionnaire were performed before and 6 months after implantation. Cardiac computed tomography was performed 2 days and 6 months after implantation. Results All procedures were completed successfully. No procedure-related adverse events occurred during the periprocedural and the follow-up periods. Angina score improved in 12 of 14 patients. Average Canadian Cardiovascular Society score was 3.07 at baseline and 1.64 at follow-up (n = 14, p Conclusions Implantation of the Coronary Sinus Reducer is feasible and safe. These findings, along with the clinical improvement observed, support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization.
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coronary sinus reducer stent for the treatment of chronic refractory angina pectoris a prospective open label multicenter safety feasibility first in man Study
Journal of the American College of Cardiology, 2007Co-Authors: Shmuel Banai, Shmuel Ben Muvhar, Keyur Parikh, Aharon Medina, Horst Sievert, Ashok Seth, Jonathan Tsehori, Yoav Paz, Ami Sheinfeld, Gad KerenAbstract:Coronary Sinus Reducer Stent for the Treatment of Chronic Refractory Angina Pectoris: A Prospective, Open Label, Multicenter Safety Feasibility First-in-Man StudyShmuel Banai, Shmuel Ben Muvhar, Ke...