Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia

Launched by CLINICAL HOSPITAL CENTRE ZAGREB · Feb 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the coronary sinus reducer (CSR), which is designed to help patients with severe chest pain (angina) caused by coronary artery disease (CAD) who cannot undergo traditional surgical treatments. The CSR is a small stent that is placed in a specific vein in the heart to improve blood flow and reduce symptoms of angina. Researchers want to find out how this device affects the small blood vessels in the heart and whether it helps improve the patients' symptoms over time.

To participate in this trial, you need to be between the ages of 65 and 74 and have coronary artery disease with ongoing chest pain that hasn't responded to other treatments. You also need to be able to sign a consent form agreeing to participate. Throughout the study, participants will undergo tests before and six months after the CSR is placed to measure changes in heart blood flow and how these changes relate to their symptoms. The trial is currently recruiting and welcomes patients of all genders who meet the eligibility criteria. This study is important as it explores a new option for patients who currently have limited treatment choices.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with coronary artery disease and refractory angina pectoris who are ineligible for coronary revascularization
• • Signed informed consent
• Exclusion Criteria:
• • Severely reduced systolic ejection fraction of the left ventricle (EF \< 35 %)
• • Severe renal impairment (eGFR \< 30ml/min/1.73m2)
• • Severe chronic obstructive pulmonary disease (GOLD D)
• • Contraindication for application of papaverine or regadenoson