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Optimization of Complex Percutaneous Coronary Intervention With Liberal Use of Intracoronary Imaging Versus Contemporary Practice

Recruitingn/aAges 18 Years - anyAllCathreine BV
NCT07114393 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Coronary artery disease remains a leading cause of mortality worldwide and is commonly treated with percutaneous coronary intervention (PCI). Typically, PCI is guided by invasive coronary angiography (ICA). However, ICA has inherent limitations in accurately assessing vessel dimensions, calcium burden, circumferential tissue and whether a stent has achieved full expansion. Therefore ICA alone is insufficient for guiding stent optimization, especially in complex lesions which are most vulnerable to long-term stent failure. To overcome the limitations of ICA, intracoronary imaging can be used to guide and optimize PCI. The advantages of intracoronary imaging include obtaining larger lumen areas, better stent expansion and strut apposition, full lesion stent coverage and identifying stent complications. Multiple randomized studies have shown that these advantages translate into a reduction

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📋 Eligibility rules (as published)
Inclusion Criteria: * All patients above the age of 18, included in the Netherlands Heart Registration (NHR) quality database after receiving PCI in complex coronary lesions, will be included in the analyses of this project. * Meeting one or more of the following complexity criteria: * Left main: A stenosis of \>50% and/or a FFR ≤ 0.80 and iFR ≤ 0.89 in the left main. * Severely calcified lesion: Defined as use of calcium modification therapy (e.g. cutting balloon, scoring balloon, rotablation, orbital atherectomy, intravascular lithotripsy). * Chronic total occlusion: Coronary CTO is defined as an obstruction of the coronary artery with the following classic lesion characteristics: * TIMI flow 0 * Absence of contrast stasis at the site of the proximal capillaries * Presence of collateral vessels * Estimated occlusion duration of at least 3 months. * Ostial lesion: Lesion at the origin (within 5 mm) of a major coronary vessel (LM, LAD, RCX and RCA). * Long lesion: A vessel treated with one or multiple stents with a total stent length of ≥38 mm is considered a long lesion. * Bifurcation (true): A coronary artery narrowing occurring adjacent to, and/or involving, the origin of a significant side branch ≥ 2.5mm. Only true bifurcation will be included, i.e. medina 1,1,1/1,0,1/0,1,1. * In-stent restenosis: A reduction ≥50% of the luminal diameter within the previously stented segment or the vessel segments 5 mm proximal and distal to the stent (the "stent edges"), as assessed by coronary angiography. Exclusion Criteria: \- Non complex PCI
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What it tests

  • Liberal use of intracoronary imaging during complex PCI
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Where

1 site
Catharina hospital Eindhoven
Eindhoven, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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