Influence of Vessel Wall Calcification on Early Stent Strut Healing

Official title

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

Overview

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.

Interventions

• Device Xience Skypoint stent over calcified coronary lesions
  Patients with Xience Skypoint stent implanted after OCT assesment of calcification

Primary outcome measures

• Mean strut coverage thickness of stent [Time frame: 1 month]

Secondary outcome measures (11)

• Proportion of covered struts [Time frame: 1 month]
• Proportion of uncovered struts [Time frame: 1 month]
• Proportion of acute post PCI malapposition struts [Time frame: 1 month]
• Proportion of malapposed struts [Time frame: 1 month]
• Proportion of the resolution of the baseline malapposition struts [Time frame: 1 month]
• Degree of endothelialization [Time frame: 1 month]
• Major adverse cardiovascular events (MACE) [Time frame: 6 months]
• All Death [Time frame: 6 months]
• Cardiac Death [Time frame: 6 months]
• Myocardial Infarction [Time frame: 6 months]
• Target Vessel Revascularization [Time frame: 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Universitari Vall Hebron — Barcelona

Publications

• 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 PMID 24561145
• 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
• 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
• 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
• 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
• 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 ran PMID 35472561

Identifiers

NCT: NCT06631755 · EPIC41-CaOCT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗