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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-27

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease Angina Pectoris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-Center Prospective Study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Coronary Sinus Reducer

Group Type EXPERIMENTAL

Coronary Sinus Reducer

Intervention Type DEVICE

Implantation of Coronary Sinus Reducer

Interventions

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Coronary Sinus Reducer

Implantation of Coronary Sinus Reducer

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No