Coronary Sinus Reducer Therapy for Persisting Angina
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUMC Utrecht
About this trial
Refractory angina due to advanced obstructive coronary artery disease (CAD) remains a major clinical problem with limited evidence-based treatment options. The coronary sinus reducer (CSR) is an hourglass-shaped stainless-steel mesh device designed to create a controlled narrowing of the coronary sinus (CS). By increasing CS pressure, CSR implantation may improve myocardial perfusion and reduce anginal symptoms, although the physiological mechanisms underlying this effect remain incompletely understood.
REDUCE-ANGINA is a prospective observational study investigating the hemodynamic effects of CSR implantation in 25 patients with refractory angina and advanced CAD. The study evaluates the interaction between coronary sinus hemodynamics and coronary arterial blood flow before and after CSR implantation. The main study endpoints include changes in coronary sinus pressure, coronary flow reserve, microvascular resistance reserve, and absolute microvascular resistance from baseline to 6 months, measured using continuous flow thermodilution during saline-induced coronary hyperemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Angina - Canadian Cardiovascular Society Class II-IV on at least two anti-anginals or maximally tolerated medical therapy if less than two.Hemodynamically significant epicardial coronary artery disease in the LAD, defined as an FFR≤0.80 and/or NHPR≤0.89.
No conventional revascularization options or considered unsuitable as determined by the local heart team.
Anatomically suitable for instrumentation of the left anterior descending coronary artery with a coronary pressure wire and infusion microcatheter.
Patient understands the nature of the procedure and provides written informed consent for the study prior to enrolment.
Disqualifiers
Age < 18 years.
Absence of symptoms reported on the ORBITA-app during the 2-week screening period.
Mean right atrial pressure ≥15 mmHg
Severe pulmonary hypertension.
Trial design
Design model
Single group
Treatments tested in this trial
Coronary sinus reducer
DeviceImpantation of coronary sinus reducer
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in coronary flow reserve
Change in coronary flow reserve from baseline to 6 months (measured by the continuous flow thermodilution technique using saline-induced coronary hyperaemia)
Time frame
Baseline and 6 months2
Angina episodes
Difference in number of daily episodes of angina recorded on the ORBITA-app at 6 month follow-up.
Time frame
Baseline and 6 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: