Influence of Vessel Wall Calcification on Early Stent Strut Healing

NCT06631755 | Recruiting DMC

• 1 other identifier: EPIC41-CaOCT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Conditions

Coronary Artery Disease

Keywords

Calcification; Strut coverage; Optical Coherence Tomography (OCT)

Outcome Measures

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).

  1 month

Secondary Outcomes (11)

• Proportion of covered struts

  1 month

• Proportion of uncovered struts

  1 month

• Proportion of acute post PCI malapposition struts

  1 month

• Proportion of malapposed struts

  1 month

• Proportion of the resolution of the baseline malapposition struts

  1 month

Study Arms (1)

Coronary Artery Disease (CAD)

OTHER

Device: Xience Skypoint stent over calcified coronary lesions

Interventions

Xience Skypoint stent over calcified coronary lesions DEVICE

Patients with Xience Skypoint stent implanted after OCT assesment of calcification

Coronary Artery Disease (CAD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (1)

Hospital Universitari Vall Hebron

Barcelona, 08035, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 24561145 BACKGROUND

• 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.

  PMID: 16326375 BACKGROUND

• 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.

  PMID: 23995714 BACKGROUND

• 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.

  PMID: 24906449 BACKGROUND

• 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.

  PMID: 24530667 BACKGROUND

• 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.

  PMID: 35472561 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Calcinosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

BRUNO GARCIA DEL BLANCO, MD, PhD

CONTACT

0034932746155; brunogb51@gmail.com

FUNDACION EPIC

CONTACT

00987876135; iepic@fundacionepic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 8, 2024
• Study Start: November 7, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

ES (1)