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NCT Number: NCT06631755

Influence of Vessel Wall Calcification on Early Stent Strut Healing

To assess the influence of superficial calcium on the early endothelialization (1 month) of the struts of the Xience Skypoint stent (comparing struts with underlying superficial calcium to struts without underlying calcification)

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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 Universitari Vall Hebron

Barcelona, 08035, Spain

Location status: Recruiting

About this study

To assess the influence of superficial calcium on the early endothelialization (1 month) of the struts of the Xience Skypoint stent (comparing struts with underlying superficial calcium to struts without underlying calcificatition by opticaL COHERENCE TOMOGRAPHY.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients who meet all the following conditions will be included:

  • Patients aged ≥ 18 years old and;
  • Patients with clinical indication for stent implantation and;
  • Patients with OCT evaluation that shows the presence of calcified tissue underlying the lumen surface, fulfilling the definition of superficial calcium (The distance from the abluminal point of the calcium to the luminal surface is less than 500 μm, in a perpendicular axis to the vessel luminal surface. When referred to the stent struts it will be assumed that such distance of less than 500 μm will be measured between the centre of the abluminal surface of the strut and the abluminal point of the calcium, in the same perpendicular axis).and;
  • Patients with good quality baseline OCT evaluation as judged by the investigators and;
  • Patients who have been briefed on the study characteristics and have given their prior written informed consent.

Exclusion criteria

  • Patients who meet, at least, 1 of the following conditions will be excluded:
  • Patients with current ST-elevation Myocardial Infarction (STEMI).
  • Patients with non-native lesion: stent restenosis, segment previously treated with drug eluting balloon, arterial or saphenous vein grafts.
  • Patients with contraindication for the 1-month follow-up angiography and OCT:
  • Glomerular Filtration Rate (GFR)< 30 ml/min/1.72m2
  • Contrast allergy
  • Baseline post-stent control OCT failure, due to tortuosity or any other reason.
  • Patient not candidate for a follow up angiography, due to frailty, non-cardiac disease or whatever other condition considered by the local team.

Treatment and study plan

Xience Skypoint stent over calcified coronary lesions

Device

Patients with Xience Skypoint stent implanted after OCT assesment of calcification

Primary outcomes

  1. Mean strut coverage thickness of stent

    Time frame: 1 month

    Mean strut coverage thickness (μ) of the stent struts located over superficial calcium will be compared to the mean strut coverage thickness of the struts in the calcium free frames by Optical Coherence Tomography (OCT).

Secondary outcomes

  1. Proportion of covered struts

    Time frame: 1 month

    proportion of covered struts (%) lying over superficial calcium compared to the proportion of covered struts in calcium free frames

  2. Proportion of uncovered struts

    Time frame: 1 month

    Proportion of uncovered struts by OCT at 1 month comparing calcified and non-calcified struts by OCT

  3. Proportion of acute post PCI malapposition struts

    Time frame: 1 month

    Proportion of acute post PCI malapposition comparing calcified and non-calcified struts by OCT

  4. Proportion of malapposed struts

    Time frame: 1 month

    Proportion of malapposed struts comparing calcified and non-calcified struts by OCT at 1 month

  5. Proportion of the resolution of the baseline malapposition struts

    Time frame: 1 month

    Proportion of the resolution of the baseline malapposition struts according to the presence of underlying superficial calcium by OCT at 1 month

  6. Degree of endothelialization

    Time frame: 1 month

    Difference in mean struck coverage thickness between calcified lesion and no calcified lesion

  7. Major adverse cardiovascular events (MACE)

    Time frame: 6 months

    Major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, cardiac death, myocardial infarction, or target vessel revascularization at 6 months

  8. All Death

    Time frame: 6 months

    Freedom from all Death

  9. Cardiac Death

    Time frame: 6 months

    Freedom from Cardiac Death

  10. Myocardial Infarction

    Time frame: 6 months

    Freedom from Myocardial Infarction

  11. Target Vessel Revascularization

    Time frame: 6 months

    Freedom from Target Vessel Revascularization

Study contacts

Contact information is provided by the study sponsor or research team.

BRUNO GARCIA DEL BLANCO, MD, PhD

CONTACT

[email protected]

0034932746155

FUNDACION EPIC

CONTACT

[email protected]

00987876135

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study title

Influence of Vessel Wall Calcification on Early Stent Strut Healing (CaOCT Study)

Acronym: CaOCT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2024
Registry last updated
Dec 19, 2025

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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