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Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

RECRUITINGSponsored by Robocath
Actively Recruiting
SponsorRobocath
Started2023-06-20
Est. completion2026-05
Eligibility
Age18 Years – 120 Years
Healthy vol.Accepted

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

Age: 18 Years – 120 YearsHealthy volunteers accepted
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.

Conditions2

Coronary DiseaseHeart Disease

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