Coronary Artery Disease
Conditions
Keywords
Calcification, Strut coverage, Optical Coherence Tomography (OCT)
Brief summary
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)
Detailed description
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.
Interventions
DEVICEXience Skypoint stent over calcified coronary lesions
Patients with Xience Skypoint stent implanted after OCT assesment of calcification
Sponsors
Fundación EPIC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean strut coverage thickness of stent | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of acute post PCI malapposition struts | 1 month | Proportion of acute post PCI malapposition comparing calcified and non-calcified struts by OCT |
| Proportion of malapposed struts | 1 month | Proportion of malapposed struts comparing calcified and non-calcified struts by OCT at 1 month |
| Proportion of covered struts | 1 month | proportion of covered struts (%) lying over superficial calcium compared to the proportion of covered struts in calcium free frames |
| Proportion of the resolution of the baseline malapposition struts | 1 month | Proportion of the resolution of the baseline malapposition struts according to the presence of underlying superficial calcium by OCT at 1 month |
| Degree of endothelialization | 1 month | Difference in mean struck coverage thickness between calcified lesion and no calcified lesion |
| Proportion of uncovered struts | 1 month | Proportion of uncovered struts by OCT at 1 month comparing calcified and non-calcified struts by OCT |
| All Death | 6 months | Freedom from all Death |
| Cardiac Death | 6 months | Freedom from Cardiac Death |
| Myocardial Infarction | 6 months | Freedom from Myocardial Infarction |
| Target Vessel Revascularization | 6 months | Freedom from Target Vessel Revascularization |
| Major adverse cardiovascular events (MACE) | 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 |
Countries
Spain
Contacts
Primary ContactBRUNO GARCIA DEL BLANCO, MD, PhD
Backup ContactFUNDACION EPIC
Outcome results
None listed