RecruitingNot ApplicableNCT06266065

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

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


Sponsor

Clinical Hospital Centre Zagreb

Enrollment

25 participants

Start Date

Feb 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria2

  • Patients with coronary artery disease and refractory angina pectoris who are ineligible for coronary revascularization
  • Signed informed consent

Exclusion Criteria4

  • 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

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Interventions

DEVICECoronary Sinus Reducer

Implantation of Coronary Sinus Reducer


Locations(1)

University Hospital Centre Zagreb

Zagreb, Croatia

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NCT06266065


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