NCT06631755 Influence of Vessel Wall Calcification on Early Stent Strut Healing
| NCT ID | NCT06631755 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación EPIC |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-11-07 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-11-07 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06631755 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06631755 currently recruiting?
Yes, NCT06631755 is actively recruiting participants. Contact the research team at brunogb51@gmail.com for enrollment information.
Where is the NCT06631755 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06631755 clinical trial?
NCT06631755 is sponsored by Fundación EPIC. The trial plans to enroll 40 participants.