Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07256249 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry

Study acronym: SELUTION
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 13 to 14v14
  2. Study sites: 12 to 13v13
  3. Study sites: 11 to 12v12
  4. Study sites: 10 to 11v11
  5. Study sites: 9 to 10v10
  6. Trial sites expanded: 6 → 9 locationsv9
  7. Study sites: 5 to 6v8
  8. Study sites: 4 to 5v7
  9. Study sites: 2 to 4v6
  10. Study sites: 1 to 2v5
  11. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Dec 30, 2025 to Dec 11, 2025v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 30, 2025 to Dec 11, 2025
  12. Start date: Dec 3, 2025 to Dec 30, 2025v3
  13. Secondary endpoints: details revised at 3 of 9 entriesv2
  14. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Fundación EPIC
32 trials monitored
See 4 trials at risk
Heart Disease
2,136 trials monitored
See 109 trials at risk
Selution Iberia registry is a post-market clinical follow-up, prospective, multicenter, international, longitudinal, observational study without a control group of consecutive unselected "real-world" patients with coronary artery disease in whom it was decided to use the SELUTION SLRTM device in the treatment of primary native lesions and ISR (in-stent restenosis) in all settings, in order to evaluate its effectiveness and safety. The primary objective is to evaluate the effectiveness and safety of the Sirolimus-eluting balloon SELUTION SLRTM based strategy in the treatment of native coronary artery stenosis and in-stent restenosis. The primary endpoint will be the incidence of major adverse cardiovascular events at 12 months, including death, non-fatal myocardial infarction or target lesion revascularization for ischemia, in an unselected "real-world" patient setting. Both Device Oriented Composite Endpoint (Cardiovascular death, device failure-related myocardial infarction or device failure-related ischaemia) and Patient Oriented Composite Endpoint (all cause death, any stroke, any myocardial infarction or any revascularization) will be detailed.
Trial Details
NCT Number NCT07256249
Lead Sponsor Fundación EPIC
Conditions Cardiovascular Diseases
Enrollment 960 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov