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Active, not recruiting Not applicable

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 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2024-03-20
Last updated
2026-04-28

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesionXIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with age ≥ 18 years AND * Patients who have signed informed consent AND * Patients with coronary artery disease requiring percutaneous treatment with coronary stents due to de novo lesions in vessels with a diameter of reference from 2.25 mm to 4.0 mm AND * Patients with at least 2 angiographic lesions in 2 different major coronary arteries. Or in the main branch and in one of its subsidiaries branches , as long as those are not "downstream" of the lesion from the main branch Exclusion Criteria: * Express refusal of the patient to participate in the study * Patients with ST elevation Myocardial Infarction or Cardiogenic Shock * Patients with high thrombotic content * Pregnant or breastfeeding patients * Patients with complex PCI (Percutaneous Coronary Intervention )(defined as): * Left main PC * Chronic total PC occlusion * Bifurcation lesion requiring 2-stent technique . * Severe calcified lesion (need to use prior complex techniques of calcium modification such as intravascular lithotripsy, rotational/orbital atherectomy, laser. * Patients with malignant neoplasms or other comorbid conditions with life expectancy \<12 months * Patients with a target lesion in a bypass graft * Lesions due to restenosis * Patients with PCI in the target vessel in the previous 9 months * Patients with contraindication or difficulty to evaluate in the follow-up with OCT (renal failure, excessive tortuosity or lesions aorto-ostial)

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)

FacilityCityRegionStatus
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
Official registry record

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