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Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II

Study acronym: COSIRA-II
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 96 to 97
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Publications: details revised at 3 of 3 entries
  2. Site details revised at 24 of 96 sitesv40
  3. Study sites: 95 to 96v39
  4. Site details revised at 22 of 95 sitesv38
  5. Primary endpoint(s) modified
    • Trial sites expanded: 91 → 95 locations
    • Eligibility criteria shortened, about 28 words
    • Secondary endpoints: 3 to 2
    v37
Show 35 earlier versionsHide 35 earlier versions
  1. Study sites: 90 to 91v36
  2. Study sites: 89 to 90v35
  3. Study sites: 83 to 89v34
  4. Study sites: 75 to 83v33
  5. Study sites: 66 to 75v32
  6. Study sites: 62 to 66v31
  7. Study sites: 60 to 62v30
  8. Primary completion date: Jun 2025 to Jul 2027v29 Show 4 more changesShow less
    • Study sites: 59 to 60
    • Study completion date: Dec 2028 to Jan 2032
    • Interventions: Arm 1: treatment with Neovasc Reducer (Device), Arm 2 (control): Implantation procedure with no device implanted (Other), Arm 3 (unblinded… to Arm 1: treatment with Shockwave Reducer (Device), Arm 2 (control): Implantation procedure with no device implanted (Other), Arm 3…
    • Eligibility criteria expanded, about 443 words
  9. Study sites: 57 to 59v28
  10. Study sites: 52 to 57v27
  11. Study sites: 50 to 52v26
  12. Study sites: 48 to 50v25
  13. Primary completion date: Jun 2024 to Jun 2025
    • Study sites: 44 to 48
    v24
  14. Study sites: 35 to 44v23
  15. Study sites: 32 to 35
    • Eligibility criteria expanded, about 17 words
    v22
  16. Study sites: 30 to 32v21
  17. Site contacts updated at 2 of 30 sitesv20
  18. Study sites: 28 to 30v19
  19. Study sites: 26 to 28v18
  20. Study sites: 23 to 26v17
  21. Study sites: 21 to 23v16
  22. Study sites: 20 to 21v15
  23. Study sites: 18 to 20v14
  24. Study sites: 17 to 18v13
  25. Study sites: 16 to 17v12
  26. Study sites: 15 to 16v11
  27. Study sites: 13 to 15v10
  28. Study sites: 12 to 13v9
  29. Re-verified, no change to tracked fieldsv8
  30. Study sites: 11 to 12
    • Interventions: Arm 1: treatment with Neovasc Reducer (Device), Arm 2 (control): Implantation procedure with no device implanted (Other) to Arm 1: treatment with Neovasc Reducer (Device), Arm 2 (control): Implantation procedure with no device implanted (Other), Arm 3 (unblinded…
    • Eligibility criteria expanded, about 954 words
    • Study arms: 2 to 3
    v7
  31. Site details revised at 2 of 11 sitesv6
  32. Study sites: 6 to 11v5
  33. Study sites: 2 to 6v4
  34. Study sites: 1 to 2v3
  35. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2021 to Jan 4, 2022
    v2
  1. 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.
To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm registry will further assess the safety and effectiveness of the Shockwave Reducer in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects without documented obstructive coronary disease and abnormal coronary flow reserve (ANOCA), and subjects who cannot complete an exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid.
Trial Details
NCT Number NCT05102019
Lead Sponsor Shockwave Medical, Inc.
Conditions
(from sponsor)		 Refractory Angina
Related terms Angina Pectoris
Enrollment 380 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov