RecruitingNCT05853419

Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

Sponsor

Robocath

Enrollment

500 participants

Start Date

Jun 20, 2023

Study Type

OBSERVATIONAL

Conditions

Coronary Disease

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

Min Age: 18 YearsMax Age: 120 Years

Inclusion Criteria4

\. Age ≥ 18 years;
Subjects with coronary artery disease with clinical indication for PCI;
Subject deemed appropriate for robotic-assisted PCI; and
The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria5

Failure/inability/unwillingness to provide informed consent, unless the ethic committee has waived informed consent; or
The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted PCI.
STEMI
Cardiogenic shock
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.

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Interventions

DEVICERobotic-assisted PCI

Robotic-assisted PCI will be performed according to the routine hospital practices, current scientific guidelines and following Instructions for Use (IFU) provided by the manufacturer