Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06214819
NA

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

View on ClinicalTrials.gov

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

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

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