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The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

Study acronym: RADIANCE-II
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 2 of 2 changed
See other at-risk trials from ReCor Medical, Inc.

Record History

The 50 most recent of 51 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 7 more changesShow less
    • Results posted: Sep 24, 2026
    • Study completion pushed from Jul 2027 to Jul 2029
    • Enrollment target: estimated 225 to confirmed 224
    • Eligibility criteria shortened, about 18 words
    • Secondary endpoints revised (7)
    • Site details revised at 7 of 47 sites
    • Publications: 3 to 4
  2. Re-verified, no change to tracked fieldsv50
  3. Study sites: 59 to 47v49
  4. Primary completion date changed from estimate of Nov 2022 to Dec 21, 2022
    • Publications: details revised at 1 of 3 entries
    v48
  5. Primary completion date: Jul 2022 to Nov 2022v47
Show 45 earlier versionsHide 45 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 67 to 59
    v46
  2. Site details revised at 4 of 67 sitesv45
  3. Primary completion date: May 2022 to Jul 2022
    • Study completion date: May 2027 to Jul 2027
    v44
  4. Study sites: 68 to 67
    • Primary completion date: Feb 2022 to May 2022
    • Study completion date: Dec 2026 to May 2027
    v43
  5. Site details revised at 1 of 68 sitesv42
  6. Study sites revised (68)v41
  7. Site details revised at 3 of 68 sitesv40
  8. Site contacts updated at 1 of 68 sitesv39
  9. Site details revised at 3 of 68 sitesv38
  10. Site details revised at 3 of 68 sitesv37
  11. Site details revised at 2 of 68 sitesv36
  12. Site contacts updated at 1 of 68 sitesv35
  13. Study sites: 67 to 68v34
  14. Study sites: 66 to 67v33
  15. Site details revised at 6 of 66 sitesv32
  16. Study sites: 61 to 66v31
  17. Study sites: 60 to 61v30
  18. Study sites: 59 to 60v29
  19. Site details revised at 8 of 59 sitesv28
  20. Study sites: 57 to 59v27
  21. Study sites: 58 to 57v26
  22. Site details revised at 1 of 58 sitesv25
  23. Primary completion date: Dec 2020 to Feb 2022
    • Study completion date: Oct 2024 to Dec 2026
    • Site details revised at 29 of 58 sites
    v24
  24. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 57 to 58
    v23
  25. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 58 to 57
    v22
  26. Site contacts updated at 3 of 58 sitesv21
  27. Site details revised at 4 of 58 sitesv20
  28. Study sites revised (58)v19
  29. Study sites: 47 to 58v18
  30. Study sites: 46 to 47v17
  31. Study sites revised (46)v16
  32. Study sites: 45 to 46v15
  33. Study sites: 44 to 45v14
  34. Study sites: 41 to 44v13
  35. Study sites: 39 to 41v12
  36. Study sites: 26 to 39v11
  37. Study sites: 24 to 26v10
  38. Study sites: 18 to 24v9
  39. Study sites: 15 to 18v8
  40. Study sites: 14 to 15v7
  41. Study sites: 7 to 14v6
  42. Study sites: 4 to 7v5
  43. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 4
    • Start date changed from estimate of Nov 2018 to Dec 14, 2018
    v4
  44. Study sites: 0 to 1
    • Start date: Oct 2018 to Nov 2018
    v3
  45. Primary endpoints revised (2)
    • Secondary endpoints revised (7)
    v2
  • 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.
ReCor Medical, Inc.
6 trials monitored
See 1 trial at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
Hypertension
1,925 trials monitored
See 99 trials at risk
The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.
Trial Details
NCT Number NCT03614260
Lead Sponsor ReCor Medical, Inc.
Conditions
(from sponsor)		 Hypertension, Vascular Diseases, Cardiovascular Diseases
Related terms Cardiovascular Diseases, Essential Hypertension, Hypertension, Vascular Diseases
Enrollment 224 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov