Change History and Adopt a Robotic SolutioN for anGioplasty procedurE (CHANGE)

Robocath

Status

Enrolling

Conditions

Coronary Disease

Treatments

Device: Robotic-assisted PCI

Study type

Observational

Funder types

NETWORK

Industry

Identifiers

NCT05853419

ROB-03

Details and patient eligibility

About

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.

Full description

The R-One system is a class "IIb" CE marked medical device designed to remote deliver and manipulate coronary guidewires and stent/balloon devices during Percutaneous Coronary Intervention (PCI). The system comprises the R-One Robotic Platform used in combination with two accessories, the Mobile Radioprotection Screen and a sterile and single-use R-One Consumable Kit. The R-One is not autonomous and operates only under the operator's commands.

This study is a single-arm, open-label, multi-center registry.

The CHANGE registry, part of the ROBOCATH's post-market clinical follow-up activities, is a real world study aiming to confirm the safety and performance, including the clinical benefit, of the R-One robotic systems medical device.

500 patients with coronary artery disease and with clinical indication for PCI will be recruited in up to Up to 15 centers distributed in Europe and South Africa.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

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.