Studies a robotic system used during heart stent procedures in people with coronary disease
Observes a robotic device used during angioplasty in adults with coronary heart disease.
Plain-language title generated from the registry record
Registry title: Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
Key facts
- Where
- Antwerp, BelgiumSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 120 years old?
Source: NCT05853419, who can take part
Where in Belgium
- Het Ziekenhuisnetwerk Antwerpen vzwAntwerp, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Robocath
- Trial code
- NCT05853419
- Record updated
- 20 August 2025
- Original description
The main objective of the CHANGE registry is the evaluation of the real-world performance and safety profile of the R-One System in PCI.Read full original descriptionShow less
Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
The main objective of the CHANGE registry is the evaluation of the real-world performance and safety profile of the R-One System in PCI.
Inclusion: 1. Age ≥ 18 years; 2.Subjects with coronary artery disease with clinical indication for PCI; 3.Subject deemed appropriate for robotic-assisted PCI; and; 4.The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion: 1.Failure/inability/unwillingness to provide informed consent, unless the ethic committee has waived informed consent; or; 2.The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted PCI; 3.STEMI; 4.Cardiogenic shock; 5.Subjects will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.