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INSPIRIS China PMCF Study

Study acronym: INSPIRIS China
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 years 2 months later Dec 2028 → Mar 2034
See other at-risk trials from Edwards Lifesciences

Record History

  1. Primary completion pushed from Dec 2028 to Mar 2034 Primary endpoints: details revised at 8 of 8 entries · Completion pushed from Dec 2029 to Dec 2034 · Study sites: 13 to 12 · 4 more Show 7 more changesShow less
    • Primary endpoints: details revised at 8 of 8 entries
    • Completion pushed from Dec 2029 to Dec 2034
    • Study sites: 13 to 12
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints revised (6)
    • Study description expanded, about 9 words
    • Collaborators: details revised at 1 of 3 entries
  2. 2 versions Re-verified since Mar 20, 2025, no change to tracked fieldsv10-v11
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 250 to confirmed 255 · Site details revised at 13 of 13 sitesv9 Show 2 more changesShow less
    • Enrollment target: estimated 250 to confirmed 255
    • Site details revised at 13 of 13 sites
  4. Study sites: 11 to 13v8
  5. Study sites: 10 to 11v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 9 to 10v6
  2. Study sites: 8 to 9 Collaborators revised (3)v5 Show 1 more changeShow less
    • Collaborators revised (3)

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 6 to 8v4
  4. Study sites: 4 to 6v3
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Start date changed from estimate of Jun 2022 to Jul 13, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 4
    • Start date changed from estimate of Jun 2022 to Jul 13, 2022
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objective of this post-market trial is to evaluate long term safety and performance of the Edwards Lifesciences INSPIRIS RESILIA aortic valve in Chinese patients in a real-world clinical setting.
Trial Details
NCT Number NCT05404880
Lead Sponsor Edwards Lifesciences
Collaborators: Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd., Rundo International Pharmaceutical Research & Development Co.,Ltd., Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions Aortic Valve Replacement
Enrollment 255 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov