Influence of Vessel Wall Calcification on Early Stent Strut Healing

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: Xience Skypoint stent over calcified coronary lesions

• Registration Number: NCT06631755
• Lead Sponsor: Fundación EPIC

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.

Study Timeline

• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-08
• Status Verified: 2024-11
• Study Start: 2024-11-07
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coronary Artery Disease (CAD)	Xience Skypoint stent over calcified coronary lesions	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 uncovered struts	1 month	Proportion of uncovered struts by OCT at 1 month comparing calcified and non-calcified struts by OCT
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 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
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
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

Trial Locations

Locations (1)

Hospital Universitari Vall Hebron; 🇪🇸 Barcelona, Spain