NCT05853419Recruiting
Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
Source: ClinicalTrials.gov · Last updated 20 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 28 Feb 2023
- Start date
- 20 Jun 2023
- Primary completion date
- May 2026
- Lead sponsor
- Robocath
- Diseases
- Coronary artery disease
- NCT number
- NCT05853419
What you commit to
- Study type: Observational
- Planned participants: 500
- From 20 Jun 2023 to the primary completion date, May 2026
- 8 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 1.Failure/inability/unwillingness to provide informed consent, unless the ethic committee has waived informed consent; or
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Het Ziekenhuisnetwerk Antwerpen vzw Coordinator of this site? Confirm its status | Antwerp | Belgium | Recruiting |
| Rheinland Klinikum Neuss GmbH Coordinator of this site? Confirm its status | Neuss | Germany | Recruiting |
| Brest University Hospital Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Rouen University Hospital Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| Centre Cardiologique du Nord Coordinator of this site? Confirm its status | Saint-Denis | France | Recruiting |
| San Donato Policlinco Kardia Coordinator of this site? Confirm its status | San Donato Milanese | Italy | Not yet recruiting |
| Polskie Towarzystwo Kardiologiczne Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Netcare Christiaan Barnard Memorial Hospital Coordinator of this site? Confirm its status | Cape Town | South Africa | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.