The Design and Feasibility of Optimal Treatment for Coronary Drug-Eluting Stent In-Stent Restenosis (OPEN-ISR)—A Prospective, Randomised, Multicentre Clinical Trial Article Swipe
Péter Márton Kulyassa
,
Balázs Tamás Németh
,
István Hizoh
,
L Jankó
,
Zoltán Ruzsa
,
Zoltán Jambrik
,
B Balázs
,
Dávid Becker
,
Béla Merkely
,
István Édes
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.3390/jpm15020060
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.3390/jpm15020060
Introduction: Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is a cornerstone of the management of ischemic heart disease. However, in-stent restenosis (ISR) remains a significant clinical challenge, occurring in approximately 5–10% of patients undergoing PCI. This study is designed to compare the efficacy and safety of the primary therapeutic approaches for DES-ISR, specifically drug-coated balloons (DCBs)—paclitaxel-coated balloons (PCBs) and sirolimus-coated balloons (SCBs)—with a new-generation everolimus-eluting stent (EES), contributing to the evolving field of personalized medicine. Methods and Analysis: This prospective, multicentre, randomised, non-inferiority trial aims to enroll 150 patients with DES-ISR, who will be randomised into one of the following: SCB, PCB, or EES. The primary endpoint comparing DCB and EES is late lumen loss (LLL) at 6 months, as measured by quantitative coronary angiography (QCA). Secondary endpoints comparing the three arms include a device-oriented composite endpoint, intraluminal gain, optical coherence tomography (OCT) measured LLL, and correlations between LLL and quantitative flow ratio (QFR). The primary endpoint will be analysed using a non-inferiority design, with a margin set at 0.25 mm, for which the sample size was calculated. Statistical analysis of the primary endpoint will be conducted on an intention-to-treat basis with a one-tailed Mann–Whitney U test with a significance level of 95. Secondary endpoints will be analysed via superiority testing using ANOVA, the Kruskal–Wallis test, logistic regression, or Fisher’s exact test, as appropriate. Ethics and Dissemination: The study protocol has been approved by the Medical Devices Department of the Hungarian National Institute of Pharmacy and Nutrition, ensuring compliance with ethical standards as outlined in the Declaration of Helsinki. All investigators declare no conflicts of interest related to this study. The trial is registered in ClinicalTrials.gov under the ID: NCT04862052.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.3390/jpm15020060
- OA Status
- gold
- References
- 17
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4407098301
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4407098301Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.3390/jpm15020060Digital Object Identifier
- Title
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The Design and Feasibility of Optimal Treatment for Coronary Drug-Eluting Stent In-Stent Restenosis (OPEN-ISR)—A Prospective, Randomised, Multicentre Clinical TrialWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2025Year of publication
- Publication date
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2025-02-02Full publication date if available
- Authors
-
Péter Márton Kulyassa, Balázs Tamás Németh, István Hizoh, L Jankó, Zoltán Ruzsa, Zoltán Jambrik, B Balázs, Dávid Becker, Béla Merkely, István ÉdesList of authors in order
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https://doi.org/10.3390/jpm15020060Publisher landing page
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YesWhether a free full text is available
- OA status
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goldOpen access status per OpenAlex
- OA URL
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https://doi.org/10.3390/jpm15020060Direct OA link when available
- Concepts
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Medicine, Clinical endpoint, Stent, Percutaneous coronary intervention, Conventional PCI, Restenosis, Everolimus, Internal medicine, Drug-eluting stent, Myocardial infarction, Randomized controlled trial, Cardiology, SurgeryTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
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17Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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