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

Coronary Artery Disease Clinical Trial

Official title:

Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia in Patients With Refractory Angina Pectoris

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06266065
• Other study ID #: 8.1-23/260-2;02/013AG
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2024
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Clinical Hospital Centre Zagreb
• Contact: Josko Bulum, MD, PhD
• Phone: +385981714090
• Email: jbulum[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (CAD). However, there remains a significant number of CAD patients who experience disability due to chronic refractory angina pectoris. These patients typically have severe diffuse CAD and are not candidates for further revascularization involving surgical coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). The installation of a coronary sinus reducer (CSR) represents a new option for percutaneous treatment of patients with refractory angina pectoris who are not suitable for surgical or percutaneous revascularization. The CSR device is designed as an hourglass-shaped stent that is positioned transcatheterally in the distal part of the coronary sinus. This increases intramyocardial venous pressure, which is believed to lead to a more favorable perfusion ratio between the ischemic subendocardial and non-ischemic subepicardial myocardium. Previous research has demonstrated that the implantation of CSR is a safe and relatively straightforward procedure. However, broader implementation and better patient selection are still limited by the fact that the exact mechanism of action remains controversial. It has not been determined why some patients have better outcomes compared to others with seemingly similar coronary artery disease. It is known that patients with atherosclerotic changes in the epicardial coronary arteries also have a certain degree of coronary microcirculation disease (the coronary vascular bed encompassing vessels with a diameter < 200 μm), which cannot be assessed through standard coronary angiography. This study aims to assess changes in coronary microcirculation after the implantation of CSR by measuring coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) before and 6 months after the procedure. Furthermore, our goal is to associate these changes with clinical symptoms and myocardial ischemia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• Coronary Sinus Reducer
Implantation of Coronary Sinus Reducer

Locations

Country	Name	City	State
Croatia	University Hospital Centre Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Centre Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of Coronary Sinus Reducer on Coronary Microcirculation	Assessment of Coronary Flow Reserve and Index of Microcirculatory Resistance before and after Coronary Sinus Reducer implantation	2 and half years
Secondary	Myocardial Ischemia assessment	Evaluation of the ischemic zone before and 6 months after the procedure using Perfusion Stress Cardiac Magnetic Resonance	2 and half years
Secondary	Angina assessment	Comparison of the severity of angina pectoris before and 6 months after the procedure using the Canadian Cardiovascular Society angina scale (CCS) and the Seattle Angina Questionnaire-7 (SAQ-7).	2 and half years
Secondary	Functional capacity assessment	Assessment of functional capacity before and 6 months after the procedure through 6 Minute Walk Test	2 and half years