Hospital Universitari Vall Hebron
Barcelona, 08035, Spain
Location status: Recruiting
NCT Number: NCT06631755
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)
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Barcelona, 08035, Spain
Location status: Recruiting
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.
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:
Exclusion criteria
Patients with Xience Skypoint stent implanted after OCT assesment of calcification
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).
Time frame: 1 month
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 by OCT at 1 month comparing calcified and non-calcified struts by OCT
Time frame: 1 month
Proportion of acute post PCI malapposition comparing calcified and non-calcified struts by OCT
Time frame: 1 month
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 according to the presence of underlying superficial calcium by OCT at 1 month
Time frame: 1 month
Difference in mean struck coverage thickness between calcified lesion and no calcified lesion
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
Time frame: 6 months
Freedom from all Death
Time frame: 6 months
Freedom from Cardiac Death
Time frame: 6 months
Freedom from Myocardial Infarction
Time frame: 6 months
Freedom from Target Vessel Revascularization
Contact information is provided by the study sponsor or research team.
BRUNO GARCIA DEL BLANCO, MD, PhD
CONTACT
FUNDACION EPIC
CONTACT
Fundación EPIC
Other
Influence of Vessel Wall Calcification on Early Stent Strut Healing (CaOCT Study)
Acronym: CaOCT
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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