Using a device to improve blood flow in patients with severe angina
Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia in Patients With Refractory Angina Pectoris
This study is testing a special device to see if it can help people with severe chest pain from heart problems feel better by improving blood flow to their heart.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Clinical Hospital Centre Zagreb Academic / other |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT06266065 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of a coronary sinus reducer (CSR) device for patients suffering from refractory angina pectoris who are not candidates for traditional revascularization methods. The CSR is an hourglass-shaped stent placed in the coronary sinus to enhance venous pressure, potentially improving blood flow to the heart muscle. The study aims to evaluate the impact of this intervention on coronary microcirculation and myocardial ischemia in patients with coronary artery disease. Participants will be closely monitored for improvements in their symptoms and heart function.
Who should consider this trial
Good fit: Ideal candidates include patients with coronary artery disease and refractory angina who are ineligible for surgical or percutaneous revascularization.
Not a fit: Patients with severely reduced left ventricular ejection fraction, severe renal impairment, or severe chronic obstructive pulmonary disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide significant relief from chronic angina symptoms for patients who currently have limited treatment options.
How similar studies have performed: While the use of coronary sinus reducers is a relatively novel approach, similar interventions have shown promise in improving outcomes for patients with refractory angina.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zagreb
- University Hospital Centre Zagreb — Zagreb, Croatia (Recruiting)
Study contacts
- Study coordinator: Josko Bulum, MD, PhD
- Email: jbulum@gmail.com
- Phone: +385981714090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.