RecruitingNot ApplicableNCT06631755
Influence of Vessel Wall Calcification on Early Stent Strut Healing
Influence of Vessel Wall Calcification on Early Stent Strut Healing (CaOCT Study)
Sponsor
Fundación EPIC
Enrollment
40 participants
Start Date
Nov 7, 2024
Study Type
INTERVENTIONAL
Conditions
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)
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria8
- 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.
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Interventions
DEVICEXience Skypoint stent over calcified coronary lesions
Patients with Xience Skypoint stent implanted after OCT assesment of calcification
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06631755
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