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.

NCT06214819 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-28

No results posted yet for this 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Fundación EPIC

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2026-07-01
Completion
2026-08-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06214819 on ClinicalTrials.gov