NCT05853419 Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
| NCT ID | NCT05853419 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Robocath |
| Condition | Coronary Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-06-20 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-06-20 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Stefan Verheye, Prof.MD
PRINCIPAL INVESTIGATOR
Het Ziekenhuisnetwerk Antwerpen vzw
Frequently Asked Questions
Who can join the NCT05853419 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Coronary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05853419 currently recruiting?
Yes, NCT05853419 is actively recruiting participants. Contact the research team at hamouda.abassi@robocath.com for enrollment information.
Where is the NCT05853419 trial being conducted?
This trial is being conducted at Antwerp, Belgium, Brest, France, Rouen, France, Saint-Denis, France and 4 additional locations.
Who is sponsoring the NCT05853419 clinical trial?
NCT05853419 is sponsored by Robocath. The principal investigator is Stefan Verheye, Prof.MD at Het Ziekenhuisnetwerk Antwerpen vzw. The trial plans to enroll 500 participants.