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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Xience Skypoint stent over calcified coronary lesions

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BRUNO GARCIA DEL BLANCO, MD, PhD; Phone Number: 0034932746155; Email: brunogb51@gmail.com
• Study Contact Backup: Name: FUNDACION EPIC; Phone Number: 00987876135; Email: iepic@fundacionepic.org

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Coronary Artery Disease (CAD)	Device: Xience Skypoint stent over calcified coronary lesions; Patients with Xience Skypoint stent implanted after OCT assesment of calcification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of covered struts	proportion of covered struts (%) lying over superficial calcium compared to the proportion of covered struts in calcium free frames	1 month
Proportion of uncovered struts	Proportion of uncovered struts by OCT at 1 month comparing calcified and non-calcified struts by OCT	1 month
Proportion of acute post PCI malapposition struts	Proportion of acute post PCI malapposition comparing calcified and non-calcified struts by OCT	1 month
Proportion of malapposed struts	Proportion of malapposed struts comparing calcified and non-calcified struts by OCT at 1 month	1 month
Proportion of the resolution of the baseline malapposition struts	Proportion of the resolution of the baseline malapposition struts according to the presence of underlying superficial calcium by OCT at 1 month	1 month
Degree of endothelialization	Difference in mean struck coverage thickness between calcified lesion and no calcified lesion	1 month
Major adverse cardiovascular events (MACE)	Major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, cardiac death, myocardial infarction, or target vessel revascularization at 6 months	6 months
All Death	Freedom from all Death	6 months
Cardiac Death	Freedom from Cardiac Death	6 months
Myocardial Infarction	Freedom from Myocardial Infarction	6 months
Target Vessel Revascularization	Freedom from Target Vessel Revascularization	6 months

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• Mosseri M, Satler LF, Pichard AD, Waksman R. Impact of vessel calcification on outcomes after coronary stenting. Cardiovasc Revasc Med. 2005 Oct-Dec;6(4):147-53. doi: 10.1016/j.carrev.2005.08.008.
• Genereux P, Madhavan MV, Mintz GS, Maehara A, Palmerini T, Lasalle L, Xu K, McAndrew T, Kirtane A, Lansky AJ, Brener SJ, Mehran R, Stone GW. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014 May 13;63(18):1845-54. doi: 10.1016/j.jacc.2014.01.034. Epub 2014 Feb 19.
• Madhavan MV, Tarigopula M, Mintz GS, Maehara A, Stone GW, Genereux P. Coronary artery calcification: pathogenesis and prognostic implications. J Am Coll Cardiol. 2014 May 6;63(17):1703-14. doi: 10.1016/j.jacc.2014.01.017. Epub 2014 Feb 12.
• Otaegui Irurueta I, Gonzalez Sucarrats S, Barron Molina JL, Perez de Prado A, Massotti M, Carmona Ramirez MA, Marti G, Bellera N, Serra B, Serra V, Domingo E, Lopez-Benito M, Sabate M, Ferreira Gonzalez I, Garcia Del Blanco B. Can an ultrathin strut stent design and a polymer free, proendothelializing probucol matrix coating improve early strut healing? The FRIENDLY-OCT trial. An intra-patient randomized study with OCT, evaluating early strut coverage of a novel probucol coated polymer-free and ultra-thin strut sirolimus-eluting stent compared to a biodegradable polymer sirolimus-eluting stent. Int J Cardiol. 2022 Aug 1;360:13-20. doi: 10.1016/j.ijcard.2022.04.043. Epub 2022 Apr 25.
• Lindsay AC, Paulo M, Kadriye K, Tejeiro R, Alegria-Barrero E, Chan PH, Foin N, Syrseloudis D, Di Mario C. Predictors of stent strut malapposition in calcified vessels using frequency-domain optical coherence tomography. J Invasive Cardiol. 2013 Sep;25(9):429-34.
• Honda Y, Toyama T, Miyaishi Y, Kan H, Kawaguchi R, Adachi H, Hoshizaki H, Oshima S. Coronary artery calcification as a new predictor of non-target lesion revascularization during the chronic phase after successful percutaneous coronary intervention. Cardiovasc Interv Ther. 2014 Oct;29(4):315-23. doi: 10.1007/s12928-014-0274-4. Epub 2014 Jun 7.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography (OCT); Calcification; Strut coverage
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Calcium Metabolism Disorders; Nutritional and Metabolic Diseases; Coronary Artery Disease; Calcinosis
• Other Study ID Numbers: EPIC41-CaOCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No