How calcium in heart artery walls affects stent healing
Studies how a heart stent heals over calcium in coronary artery disease patients.
Plain-language title generated from the registry record
Registry title: Influence of Vessel Wall Calcification on Early Stent Strut Healing
Key facts
- Where
- Barcelona, SpainSee the site
Where in Spain
- Hospital Universitari Vall HebronBarcelona, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación EPIC
- Trial code
- NCT06631755
- Record updated
- 19 December 2025
- Original 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 calcification)Read full original descriptionShow less
Influence of Vessel Wall Calcification on Early Stent Strut Healing (CaOCT 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 calcification)
Inclusion: 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: Patients with non-native lesion: stent restenosis, segment previously treated with drug eluting balloon, arterial or saphenous vein grafts; Patients who meet, at least, 1 of the following conditions will be excluded:; Patients with current ST-elevation Myocardial Infarction (STEMI); Patient not candidate for a follow up angiography, due to frailty, non-cardiac disease or whatever other condition considered by the local team; 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.