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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.
Sponsor: Fundación EPIC
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.
Official title: Randomized, Controlled, Open-label, Double-blind, Multicenter Investigation 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-03-20
Completion Date
2026-05-31
Last Updated
2026-01-21
Healthy Volunteers
No
Conditions
Interventions
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
Locations (4)
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