Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

Conditions
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Coronary Disease

Intervention / Treatment
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* Device: Robotic-assisted PCI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study population<br>Adult patients with coronary artery disease and a clinical indication for PCI | Device: Robotic-assisted PCI<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success | Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the R-One System, without in-hospital major adverse cardiac events (MACE). | From Day 0 to Day 3 | 
| Technical success | Absence of any unplanned manual assistance or conversion to manual PCI for procedural completion | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation exposure for the patient | Dose (DSP and Air Kerma) measured by the imaging system during the procedure. | During procedure | 
| Overall Procedure Time | Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. | During procedure | 
| Overall contrast volume | Total volume of contrast (mL) used during the procedure. | During procedure | 
| Radiation exposure for the operator | Cumulative dose the operator receives as recorded from an electronic pocket dosimeter during the procedure. | During procedure | 
| Fluoroscopy Time | Total fluoroscopy utilized during the procedure as recorded by an Imaging System. | During procedure | 
| Safety event occurrence | Medical device's safety event occurrence | From Day 0 to Day 3 |