Impact of Calcium on Stent Healing in Coronary Artery Disease

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

This study tests how the presence of calcium affects the healing of stents in patients with coronary artery disease to see if it makes a difference in recovery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundación EPIC (Academic / other)
• Locations: 1 site (Barcelona)
• Trial ID: NCT06631755 on ClinicalTrials.gov

What this trial studies

This study evaluates how superficial calcium affects the early healing of stent struts in patients with coronary artery disease. It specifically compares the endothelialization of struts placed over calcified lesions to those without underlying calcification using Optical Coherence Tomography (OCT). The study aims to provide insights into the optimal conditions for stent implantation and healing, potentially improving patient outcomes. Participants will undergo OCT evaluations to assess the presence of superficial calcium before stent placement.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who require stent implantation and have OCT-confirmed superficial calcium beneath the stent site.

Not a fit: Patients without calcified lesions or those who do not require stent implantation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved stent designs and techniques that enhance healing and reduce complications in patients with coronary artery disease.

How similar studies have performed: While studies on stent healing exist, this specific focus on superficial calcium's impact is relatively novel and has not been extensively tested.

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.

Where this trial is running

Barcelona

• Hospital Universitari Vall Hebron — Barcelona, Spain (Recruiting)

Study contacts

• Study coordinator: BRUNO GARCIA DEL BLANCO, MD, PhD

Conditions Coronary Artery Disease; Calcification; Strut coverage; Optical Coherence Tomography