COSIRA II Clinical Trial

Refractory Angina Patients: An Underserved Population

Usually a symptom of myocardial ischemia (a lack of blood flow to the heart muscle), angina may feel like pressure or squeezing in the chest and/or pain in the shoulders, arms, neck, jaw or back. Many patients experiencing angina suffer symptoms that are severe, long-lasting and uncontrollable by traditional medical therapies. This severely debilitating condition is known as refractory angina.

• Angina pain is often a symptom of coronary artery disease (CAD), when plaque buildup occurs in the arteries supplying the oxygen-rich blood to the heart, forcing the heart to work harder.
• Many patients can get relief from their angina through revascularization from a coronary intervention or surgery. However, 20–40% continue to suffer from angina even after successful revascularization.^{1, 2} 
• Angina with nonobstructive coronary arteries (ANOCA) is increasingly recognized and may affect nearly half of all patients with angina.³

Percutaneous Treatment Option for Refractory Angina

Shockwave Reducer, an investigational device in the United States currently being studied in the COSIRA II trial (COSIRA = COronary SInus Reducer for treatment of Refractory Angina II), is an innovative technology designed to treat symptoms of refractory angina by creating a permanent, controlled narrowing of the coronary sinus. The resulting increase in back pressure reduces angina symptoms by a hypothesized redistribution of blood into the ischemic myocardium.⁴

COSIRA II is Currently Enrolling Patients

COSIRA II is a multicenter, randomized, double-blind, sham-controlled trial designed to demonstrate the safety and effectiveness of the Shockwave Reducer 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 Shockwave Reducer in three additional patient types:

• Patients with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization
• Patients with reversible myocardial ischemia without documented obstructive coronary disease
• Patients who cannot complete an exercise tolerance test due to an above-the-ankle amputation

For a full list of inclusion and exclusion criteria, visit: Study Details | Efficacy of the COronary SInus Reducer in Patients with Refractory Angina II | ClinicalTrials.gov

COSIRA II Participating Sites

Building on Clinical Data: COSIRA II Trial

Currently enrolling: COSIRA II is the next-phase clinical trial designed to gather further evidence of the safety and effectiveness of Shockwave Reducer. The study is a U.S.-based, multicenter, randomized, double-blind, sham-controlled trial. ClinicalTrials.gov Identifier: NCT05102019.

1: Crea F, et al. European Heart Journal. 2019 Aug 1;40(29):2455-62.
2: Singh A. European Heart Journal. 2024 Oct 28; 45 (Supplement_1): ehae666.1457
3: Perera D, Berry C, Hoole SP, et al. Heart 2023;109:88–95;
4: Verheye, Stefan, et al. JACC: Cardiovascular Interventions, vol. 17, no. 24, 2024, pp. 2908-2918.