Actively Recruiting
Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia in Patients With Refractory Angina Pectoris
Led by Clinical Hospital Centre Zagreb · Updated on 2024-03-06
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of a coronary sinus flow reducer device on patients with coronary artery disease (CAD) who have chronic refractory angina pectoris and are not candidates for further coronary bypass or angioplasty procedures. These patients have severe, widespread CAD and often experience disability. The study seeks to understand changes in coronary microcirculation after device implantation by measuring coronary flow reserve and microcirculatory resistance, linking these changes to symptoms and heart muscle ischemia. The study involves implanting a coronary sinus reducer, an hourglass-shaped stent placed in the coronary sinus through a catheter. This device increases venous pressure in the heart muscle, potentially improving blood flow balance between different heart areas. The implantation is minimally invasive, and its exact mechanism is still being studied. The main treatment period includes the implantation and follow-up assessments over six months. Participants will be monitored with tests measuring coronary microcirculation, heart muscle ischemia, angina symptoms, and functional capacity over two and a half years. Researchers will assess these outcomes before and after device implantation. Safety and clinical symptom changes will also be tracked throughout the study, which is sponsored by the Clinical Hospital Centre Zagreb and runs until June 2026.
CONDITIONS
Brief Title
Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with coronary artery disease and refractory angina pectoris who are ineligible for coronary revascularization
- Signed informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure with immediate recovery period
Participants undergo implantation of the Coronary Sinus Reducer device.
1 visit (in-person)
Duration - Up to 2 and a half years
Participants are monitored to assess the impact of the Coronary Sinus Reducer on coronary microcirculation, myocardial ischemia, angina, and functional capacity.
Trial Site Locations
Total: 1 location
1
University Hospital Centre Zagreb
Zagreb, Croatia, 10000
Actively Recruiting
Research Team
J
Josko Bulum, MD, PhD
L
Luka Percin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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