Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
ConditionCoronary Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorRobocath
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Robotic-assisted PCI
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
Robocath
Lead sponsor
European Cardiovascular Research Center
Collaborator
Source ClinicalTrials.gov