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

Study acronym: COSIMA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary completion date: Oct 20, 2024 to Oct 20, 2025v5
  2. Primary completion date: Oct 20, 2022 to Oct 20, 2024
    • Study completion date: Oct 20, 2027 to Oct 20, 2029
    v4
  3. Start date changed from estimate of Mar 1, 2021 to Apr 1, 2021v3
  4. Start date: Oct 20, 2020 to Mar 1, 2021v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04606459
Lead Sponsor Johannes Gutenberg University Mainz
Collaborators: Shockwave Medical, Inc.
Conditions
(from sponsor)		 Coronary Microvascular Disease, Refractory Angina
Related terms Angina Pectoris, Microvascular Angina
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov