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RESOLUTE ONYX China Single Arm Study

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

Record History

  1. Completion date: Apr 30, 2026 to Aug 30, 2026v20
  2. Completion date: Oct 2, 2025 to Apr 30, 2026v19
  3. Secondary endpoints: details revised at 3 of 15 entriesv18
  4. 7 versions Re-verified since Apr 22, 2022, no change to tracked fieldsv11-v17
  5. Completion date: Dec 24, 2024 to Oct 2, 2025v10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date changed from estimate of Mar 31, 2021 to Feb 24, 2021v9
  2. Primary completion date: Sep 30, 2020 to Mar 31, 2021 Completion date: Sep 30, 2024 to Dec 24, 2024v8 Show 1 more changeShow less
    • Completion date: Sep 30, 2024 to Dec 24, 2024
  3. 2 versions Re-verified since Nov 18, 2019, no change to tracked fieldsv6-v7
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 585 to confirmed 591 · Site details revisedv5 Show 2 more changesShow less
    • Enrollment target: estimated 585 to confirmed 591
    • Site details revised
  5. 2 versions Re-verified since Oct 9, 2018, no change to tracked fieldsv3-v4
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Mar 31, 2018 to Mar 30, 2018v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 31, 2018 to Mar 30, 2018
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyx™ Stent System in China.
Trial Details
NCT Number NCT03471845
Lead Sponsor Medtronic Vascular
Conditions Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease
Enrollment 591 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov