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
- Neuss, GermanySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with coronary artery disease who need a PCI (a procedure that opens narrowed heart arteries) and can have it done with a robotic system.
- Age
- 18 years or older (up to 120 years)
- Sex
- All sexes can join.
- Disease stage
- Coronary artery disease with a clinical need for PCI. People with STEMI or cardiogenic shock cannot join.
Main reasons for not taking part
- Cannot give informed consent, unless the ethics committee has waived consent
- The investigator decides the person or the heart artery anatomy is not fit for robotic-assisted PCI
- STEMI (a major type of heart attack)
- Cardiogenic shock
- Under judicial protection, guardianship or curatorship, or deprived of liberty by a judicial or administrative decision
Read by machine on 12 November 2026.
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 Germany
- Rheinland Klinikum Neuss GmbHNeuss, GermanyContact: Michael Haude, Prof.MDTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.