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.
Condition(s) studied
Investigational drug(s) / intervention(s)
VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion: VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion
XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion: XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion
Study summary
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.
Eligibility
Primary outcome measure(s)
- Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation — 1 month
Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation - Percentage of stents with uncovered struts at 1 month OCT after stent implantation — 1 month
Percentage of stents with uncovered struts (0μm) at 1 month OCT after stent implantation - Mean thickness of struts tissue coverage at 1 month OCT after stent implantation — 1 month
Mean thickness of struts tissue coverage at 1 month OCT after stent implantation
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Universitari Vall D'Hebron | Barcelona | Spain | |
| Hospital Clinic Barcelona | Barcelona | Spain | |
| Hospital Universitario de Gerona Doctor Josep Trueta | Girona | Spain | |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Spain |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06214819 on ClinicalTrials.gov ↗ ← All trials in Spain