Status:
COMPLETED
CoROnary SinuS Reducer implantatiOn for ischemiA reDuction
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Refractory Angina Pectoris
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Patients with refractory angina pectoris have low quality of life and reduced exertional capacity. Studies have shown that the coronary sinus reducer (CSR) implantation improves the quality of life. H...
Eligibility Criteria
Inclusion
- angina pectoris CCS class II-IV
- receiving optimal medical therapy for at least one month
- confirmed reversible myocardial ischemia in left anterior descending coronary artery (LAD) and/or left circumflex coronary artery (LCX) territory by SPECT
- not candidate for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
Exclusion
- recent non stable angina pectoris (within 1 months)
- recent acute coronary syndrome (within 3 months)
- recent successful PCI and/or CABG (within 6 months)
- decompensated heart failure and/or recent (within 3 months) hospitalization due to heart failure
- severe heart valve(s) disease
- advanced chronic obstructive pulmonary disease (COPD) or poorly managed asthma
- peripheral arterial disease, musculoskeletal disorder or central nervous system disease which preclude exercise testing
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04121845
Start Date
January 1 2019
End Date
June 30 2022
Last Update
July 25 2022
Active Locations (1)
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1
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000