Health TrialsbyHealthPanel

Influence of Vessel Wall Calcification on Early Stent Strut Healing

ConditionCoronary Artery Disease
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Xience Skypoint stent over calcified coronary lesions

    Device

    Patients with Xience Skypoint stent implanted after OCT assesment of calcification

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Coronary Artery Disease (CAD)Other 1 intervention

Trial outcomes

Primary outcomes

1

Mean strut coverage thickness of stent

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).

Time frame
1 month

Secondary outcomes

1

Proportion of covered struts

proportion of covered struts (%) lying over superficial calcium compared to the proportion of covered struts in calcium free frames

Time frame
1 month
2

Proportion of uncovered struts

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

Time frame
1 month
3

Proportion of acute post PCI malapposition struts

Proportion of acute post PCI malapposition comparing calcified and non-calcified struts by OCT

Time frame
1 month
4

Proportion of malapposed struts

Proportion of malapposed struts comparing calcified and non-calcified struts by OCT at 1 month

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación EPIC

Lead sponsor

Source ClinicalTrials.gov
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