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FORWARD CAD IDE Study

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site details revised at 1 of 34 sitesv37
  2. Site details revised at 1 of 34 sitesv36
  3. Site details revised at 1 of 34 sitesv35
  4. Primary completion date: Dec 5, 2025 to Dec 8, 2025
    • Site details revised at 1 of 34 sites
    v34
  5. Site details revised at 5 of 34 sitesv33
Show 31 earlier versionsHide 31 earlier versions
  1. Site details revised at 13 of 34 sitesv32
  2. Site details revised at 7 of 34 sitesv31
  3. Site details revised at 4 of 34 sitesv30
  4. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 34 of 34 sites
    v29
  5. Enrollment target: 158 to 408
    • Study description expanded, about 25 words
    v28
  6. Primary completion date changed from estimate of Aug 2026 to Dec 5, 2025
    • Study completion date: Jul 2028 to Dec 2027
    v27
  7. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 34 of 34 sites
    v26
  8. Study sites: 33 to 34v25
  9. Study sites: 30 to 33v24
  10. Study sites: 29 to 30v23
  11. Study sites: 28 to 29v22
  12. Study sites: 27 to 28v21
  13. Study sites: 26 to 27v20
  14. Study sites: 25 to 26v19
  15. Study sites: 24 to 25v18
  16. Study sites: 21 to 24v17
  17. Study sites: 20 to 21v16
  18. Study sites: 18 to 20v15
  19. Study sites: 17 to 18v14
  20. Study sites: 15 to 17v13
  21. Study sites: 14 to 15v12
  22. Study sites: 12 to 14v11
  23. Study sites: 11 to 12v10
  24. Study sites: 8 to 11v9
  25. Study sites: 7 to 8v8
  26. Study sites: 3 to 7v7
  27. Study sites: 2 to 3v6
  28. Start date changed from estimate of Apr 2025 to Apr 4, 2025v5
  29. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    v4
  30. Study site revisedv3
  31. Study sites: 0 to 1v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The FORWARD CAD IDE Study is a Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study conducted to assess the safety and effectiveness of the Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Coronary IVL Catheter for the treatment of calcified, stenotic de novo coronary artery lesions prior to stenting.
Trial Details
NCT Number NCT06662500
Lead Sponsor Shockwave Medical, Inc.
Conditions
(from sponsor)		 Coronary Arterial Disease (CAD)
Enrollment 408 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov