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NCT Number: 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.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic Barcelona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Device

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

Device

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

Primary outcomes

  1. Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation

    Time frame: 1 month

    Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation

  2. Percentage of stents with uncovered struts at 1 month OCT after stent implantation

    Time frame: 1 month

    Percentage of stents with uncovered struts (0μm) at 1 month OCT after stent implantation

  3. Mean thickness of struts tissue coverage at 1 month OCT after stent implantation

    Time frame: 1 month

    Mean thickness of struts tissue coverage at 1 month OCT after stent implantation

Secondary outcomes

  1. Percentage of malapposition of stent at 1 month OCT after stent implantation

    Time frame: 1 month

    Percentage of malapposition of stent at 1 month OCT after stent implantation

  2. Percentage of covered struts at 1 months OCT after stent implantation

    Time frame: 1 month

    Percentage of covered struts at 1 months OCT after stent implantation

  3. All-Cause Death Rate at 6 months

    Time frame: 6 months

    All-Cause Death Rate at 6 months

  4. Cardiac Death Rate at 6 months

    Time frame: 6 months

    Cardiac Death Rate at 6 months

  5. Myocardial Infarction Rate at 6 months

    Time frame: 6 months

    Myocardial Infarction Rate at 6 months

  6. Target vessel revascularization Rate at 6 months

    Time frame: 6 months

    Target vessel revascularization Rate at 6 months

  7. Neointimal Healing Score (NHC) by OCT at 1 month

    Time frame: 1 months

    The NHS is then calculated as follows:

    • Presence of filling defect (% intraluminal defect, ILD) is assigned a weight of "4"
    • Presence of both malapposed and uncovered struts (% malapposed/uncovered, MU) is assigned a weight of "3"
    • Presence of uncovered struts alone (% malapposed, M) is assigned a weight of "2"
    • Presence of malapposed struts alone (% uncovered, U) is assigned a weight of "1" Neointimal healing score = (%ILD * 4)+(%MU * 3)+(%U * 2)+(%M * 1).
  8. Percentage of malapposed total struts at 1 month

    Time frame: 1 month

    Percentage of malapposed total struts at 1 month

  9. Percentage of malapposed scaffold struts over side branch at 1 month

    Time frame: 1 month

    Strut malapposition: Measured maximum distance ≥100 μm between the strut surface and adjacent vessel surface by OCT, considering thickness of scaffold, was defined as malapposition. As a result, scaffold malapposition is defined as the presence of any malapposed struts. The ratio of malapposed struts (% malapposed strut) was the ratio of malapposed struts from total analyzable struts.

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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