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NCT06631755Recruiting

Influence of Vessel Wall Calcification on Early Stent Strut Healing

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

Source: ClinicalTrials.gov · Last updated 19 Dec 2025

Brief summary (registry, in English)

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)

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
2 Oct 2024
Start date
7 Nov 2024
Primary completion date
1 May 2026
Lead sponsor
Fundación EPIC
NCT number
NCT06631755

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 7 Nov 2024 to the primary completion date, 1 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with non-native lesion: stent restenosis, segment previously treated with drug eluting balloon, arterial or saphenous vein grafts.

Other illness

  • 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.

Lab values

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Vall Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.