Clinical Trial

COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina

Study acronym: COSIMA
Recruiting
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Record status
This record was last updated September 28, 2023 (before its estimated October 20, 2025 completion). Its status may not reflect the trial's current state.
Summary
Patients with refractory microvascular angina fulfilling the predefined inclusion and exclusion criteria will be enrolled in this randomized trial. The primary objective is to investigate whether the proportion of patients reporting an improvement in Canadian Cardiovascular Society (CCS) angina class (≥2 classes) is different at six months after implantation of a Coronary Sinus Reducer followed by optimal medical therapy (OMT) compared to OMT alone.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2020-10-22; most recent amendment 2023-09-26.
Trial Details
NCT Number NCT04606459
Lead Sponsor Johannes Gutenberg University Mainz
Collaborators: Shockwave Medical, Inc.
Conditions Coronary Microvascular Disease, Refractory Angina
Enrollment 144 participants
Start Date 2021-04-01
Primary Completion 2025-10-20 (estimated)
Study Completion 2029-10-20 (estimated)
Updated on ClinicalTrials.gov 2023-09-28