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RESOLUTE ONYX China RCT Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion date: Apr 30, 2026 to Jul 31, 2026v20
  2. Completion date: Sep 19, 2025 to Apr 30, 2026v19
  3. 7 versions Re-verified since Apr 22, 2022, no change to tracked fieldsv12-v18
  4. Completion date: Dec 11, 2024 to Sep 19, 2025v11
  5. Primary completion date changed from estimate of Mar 31, 2021 to Feb 12, 2021 Study sites revised (2)v10 Show 1 more changeShow less
    • Study sites revised (2)

    See this version in full on ClinicalTrials.gov ↗

Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date: Sep 30, 2020 to Mar 31, 2021 Completion date: Nov 30, 2024 to Dec 11, 2024v9 Show 1 more changeShow less
    • Completion date: Nov 30, 2024 to Dec 11, 2024
  2. 2 versions Re-verified since Nov 18, 2019, no change to tracked fieldsv7-v8
  3. Trial status: Recruiting to Active, Not Recruiting Site details revised at 2 of 2 sitesv6 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  4. 2 versions Re-verified since Oct 9, 2018, no change to tracked fieldsv4-v5
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 2 · Start date changed from estimate of Mar 31, 2018 to Apr 12, 2018v3 Show 2 more changesShow less
    • Study sites: 1 to 2
    • Start date changed from estimate of Mar 31, 2018 to Apr 12, 2018
  6. Eligibility criteria expanded, about 78 wordsv2 See this version in full on ClinicalTrials.gov ↗
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
It is a randomized controlled trial to evaluate the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic Resolute Integrity™ Zotarolimus-Eluting coronary stent system in the treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) in China.
Trial Details
NCT Number NCT03466151
Lead Sponsor Medtronic Vascular
Conditions Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov