Clinical Trials Logo
  1. Home
  2. Refractory Angina
  3. NCT05102019

Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II — COSIRA-II  

Refractory Angina Clinical Trial

Official title:
Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II

Clinical Trial Summary

To demonstrate the safety and effectiveness of the Reducer system for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm will further assess the safety and effectiveness of the Neovasc Reducer System in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects with reversible myocardial ischemia without documented obstructive coronary disease and subjects who cannot complete an exercise tolerance test due to an above-the-ankle amputation.

Clinical Trial Description

The COSIRA-II study is a multicenter, randomized (1:1 ratio), double-blinded, sham-controlled clinical trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05102019
Study type Interventional
Source Neovasc Inc.
Contact COSIRA-II Study Team
Phone 877-775-4846
Email ReducerIDE@neovasc.com
Status Recruiting
Phase N/A
Start date January 4, 2022
Completion date December 2028
View Details
See also
  Status Clinical Trial Phase
Completed NCT01205893 - Coronary Sinus Reducer for Treatment of Refractory Angina - COSIRA Phase 2
Not yet recruiting NCT05711849 - Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina Phase 2
Suspended NCT04306237 - A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Refractory Angina Phase 2
Recruiting NCT04892537 - Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance N/A
Completed NCT00694642 - Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis Phase 1/Phase 2
Suspended NCT00820586 - Intramyocardial Delivery of Autologous Bone Marrow Phase 2
Recruiting NCT04368819 - Allopurinol in Patients With Refractory Angina to Improve Ischemic Symptoms Phase 2/Phase 3
Recruiting NCT03455725 - CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial N/A
Completed NCT01966042 - Study Protocol of Intramyocardial Injection of Autologous Bone Marrow Stem Cells for Refractory Angina Phase 2
Recruiting NCT03991871 - HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study N/A
Completed NCT03218891 - Cardiac Rehabilitation in Patients With Refractory Angina N/A
Completed NCT01796912 - Lipoprotein Apheresis in Refractory Angina Study N/A
Completed NCT03350737 - Coronary Arteriogenetic Heparinized Exercise N/A
Recruiting NCT01566175 - Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Ngina Class 3-4 Who Are Not Candidates for Revascularization N/A
Recruiting NCT05492110 - Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction. N/A
Recruiting NCT04606459 - COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina N/A