Influence of Vessel Wall Calcification on Early Stent Strut Healing (CaOCT)

Fundación EPIC

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Xience Skypoint stent over calcified coronary lesions

Study type: Interventional

Funder types: Other

Identifiers

NCT06631755

EPIC41-CaOCT

Details and patient eligibility

About

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)

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Coronary Artery Disease (CAD)

Other group

Treatment:

Device: Xience Skypoint stent over calcified coronary lesions