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Plan to Evaluate Early Endothelialization of a Polymer Free Sirolimus-eluting Coronary Stent System (VIVO ISARTM) Compared With Everolimus-eluting Durable Polymer Stent (XIENCE SkypointTM) in Patients Undergoing Percutaneous Coronary Intervention.

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 28, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion pushed from Apr 1, 2026 to Jul 1, 2026 Completion pushed from May 31, 2026 to Aug 31, 2026v8 Show 1 more changeShow less
    • Completion pushed from May 31, 2026 to Aug 31, 2026
  2. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Jan 1, 2026 to Apr 1, 2026 · Completion date: Jan 31, 2026 to May 31, 2026 · Site details revised at 4 of 4 sitesv7 Show 3 more changesShow less
    • Primary completion date: Jan 1, 2026 to Apr 1, 2026
    • Completion date: Jan 31, 2026 to May 31, 2026
    • Site details revised at 4 of 4 sites
  3. Re-verified, no change to tracked fieldsv6
  4. Study sites: 3 to 4v5
  5. Study sites: 2 to 3v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 1 to 2v3
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jan 30, 2024 to Mar 20, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 30, 2024 to Mar 20, 2024
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To evaluate the stent endothelialization (\> 20 microns) of VIVO ISARTM versus XIENCE SkypointTM stents at 1-month (very early strut covered) at follow-up by Optical Coherence Tomography (OCT) implanted IN THE SAME PATIENT during routine clinical practice.
Trial Details
NCT Number NCT06214819
Lead Sponsor Fundación EPIC
Conditions Coronary Artery Disease
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov