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

NCT06266065 | Recruiting

• 1 other identifier: 8.1-23/260-2;02/013AG
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Angina Pectoris

Keywords

Coronary Sinus Reducer; Myocardial Ischemia; Coronary Microcirculation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Myocardial Ischemia assessment

  2 and half years

• Angina assessment

  2 and half years

• Functional capacity assessment

  2 and half years

Study Arms (1)

Coronary Sinus Reducer

EXPERIMENTAL

Device: Coronary Sinus Reducer

Interventions

Coronary Sinus Reducer DEVICE

Implantation of Coronary Sinus Reducer

Coronary Sinus Reducer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb: lead

Study Sites (1)

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Josko Bulum, MD, PhD

CONTACT

+385981714090; jbulum@gmail.com

Luka Percin, MD

CONTACT

+385917917252; luka.percin555@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal Investigator

Model Details: Single-Center Prospective Study

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 20, 2024
• Study Start: February 27, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

CR (1)