Influence of Vessel Wall Calcification on Early Stent Strut Healing

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación EPIC

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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.

Glomerular Filtration Rate (GFR)< 30 ml/min/1.72m2

Contrast allergy

Trial design

Treatments tested in this trial

  • Xience Skypoint stent over calcified coronary lesions

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators