Clinical trial NCT06631755: Influence of Vessel Wall Calcification on Early Stent Strut Healing
Official title: Influence of Vessel Wall Calcification on Early Stent Strut Healing (CaOCT Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Calcification
Strut coverage
Optical Coherence Tomography (OCT)
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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.

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.

Primary outcomes:
measure: Mean strut coverage thickness of stent
timeFrame: 1 month
Secondary outcomes:
measure: Proportion of covered struts
timeFrame: 1 month
measure: Proportion of uncovered struts
timeFrame: 1 month
measure: Proportion of acute post PCI malapposition struts
timeFrame: 1 month
measure: Proportion of malapposed struts
timeFrame: 1 month
measure: Proportion of the resolution of the baseline malapposition struts
timeFrame: 1 month
measure: Degree of endothelialization
timeFrame: 1 month
measure: Major adverse cardiovascular events (MACE)
timeFrame: 6 months
measure: All Death
timeFrame: 6 months
measure: Cardiac Death
timeFrame: 6 months
measure: Myocardial Infarction
timeFrame: 6 months
measure: Target Vessel Revascularization
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall Hebron
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.