An interventional study of Xience Skypoint stent over calcified coronary lesions in Coronary Artery Disease, sponsored by Fundación EPIC. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Fundación EPIC · Not applicable, Interventional, and Treatment
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)
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 40 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Fundación EPIC is the lead sponsor of 48 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who meet all the following conditions will be included:
Exclusion Criteria:
Patients with for the 1-month follow-up angiography and OCT:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Xience Skypoint stent over calcified coronary lesions
Patients with Xience Skypoint stent implanted after OCT assesment of calcification
Mean strut coverage thickness of stent
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).
Time frame: 1 month
Proportion of covered struts
proportion of covered struts (%) lying over superficial calcium compared to the proportion of covered struts in calcium free frames
Time frame: 1 month
Proportion of uncovered struts
Proportion of uncovered struts by OCT at 1 month comparing calcified and non-calcified struts by OCT
Time frame: 1 month
Proportion of acute post PCI malapposition struts
Proportion of acute post PCI malapposition comparing calcified and non-calcified struts by OCT
Time frame: 1 month
Proportion of malapposed struts
Proportion of malapposed struts comparing calcified and non-calcified struts by OCT at 1 month
Time frame: 1 month
Proportion of the resolution of the baseline malapposition struts
Proportion of the resolution of the baseline malapposition struts according to the presence of underlying superficial calcium by OCT at 1 month
Time frame: 1 month
Degree of endothelialization
Difference in mean struck coverage thickness between calcified lesion and no calcified lesion
Time frame: 1 month
Major adverse cardiovascular events (MACE)
Major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, cardiac death, myocardial infarction, or target vessel revascularization at 6 months
Time frame: 6 months
All Death
Freedom from all Death
Time frame: 6 months
Cardiac Death
Freedom from Cardiac Death
Time frame: 6 months
Myocardial Infarction
Freedom from Myocardial Infarction
Time frame: 6 months
Target Vessel Revascularization
Freedom from Target Vessel Revascularization
Time frame: 6 months
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