NCT06214819

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.

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.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fundación EPIC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	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
DEVICE	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

Timeline

• Start date: 2024-03-20
• Primary completion: 2026-04-01
• Completion: 2026-05-31
• First posted: 2024-01-22
• Last updated: 2026-01-21

Locations

4 sites across 1 country: Spain