First in Human Trial of R-Star: A Novel Robotic System for Minimally Invasive Coronary Artery Procedures.

the R-STAR PCI FIH study is a prospective, interventional, first-in-human, exploratory, single-arm, open-label, pre-marketing pilot study conducted at a single site.

This study is designed to evaluate the safety and performance of the R-Two system, as well as the clinical feasibility of its use under normal conditions of use, in accordance with the General Safety and Performance Requirements pertaining to clinical evaluation of the device, as per Annex I of the Medical Device Regulation MDR 2017/745 (EU).

The study includes four visits. The baseline visit is performed prior to the index procedure and includes subject screening and eligibility verification as well as the informed consent process. The procedure visit (Day 0) corresponds to the index RA-PCI performed with the R-Two System and includes peri-procedural assessments. The post-procedure/hospital discharge visit (Day +1) allows for early follow-up and safety evaluation. Finally, the 30-day post-procedure visit (Day 30 ±7) is conducted to assess clinical status and collect follow-up information.

Based on preclinical findings and prior experience with robotic-assisted PCI, the R-Two platform is expected to demonstrate high levels of technical and clinical performance and safety in the intended population. The system is designed to reduce operator radiation exposure and to improve ergonomics by enabling remote operation from a control room, thereby limiting physical strain. Clinical outcomes are anticipated to be favorable, with low complication rates and improved operator working conditions. Secondary endpoints, such as procedure duration, fluoroscopy time, and contrast agent volume, are also expected to remain within clinically acceptable ranges.

Inclusion criteria

• Subjects eligible for inclusion in this study must meet all of the following inclusion criteria:
• Patient ≥ 18 years old;
• Patient with confirmed CAD, with indication for elective PCI;
• Patient with CAD presenting the following specifications:

• de novo native coronary artery lesion (i.e. a coronary lesion not previously treated)
• Study reference vessel diameter is between 2.5 mm and 4.0 mm by visual estimate
• Study lesion diameter showing stenosis of at least 50% by visual estimate.
• Subject deemed appropriate for robotic-assisted PCI with R-Two system used per its intended use; based on the investigator's judgment;
• The patient provides written informed consent as approved by the applicable Ethics Committee and is willing to comply with all study requirements including 30 day follow-up;
• The patient is affiliated with a social security system.
• Female subjects must be of non-child bearing potential, or if able to bear children, have a negative urinary pregnancy test within 7 days prior to the intended index procedure.

Exclusion criteria

• Planned PCI or coronary artery bypass graft (CABG) within 30 days after the study procedure.
• Acute myocardial infarction within 72 hours before the study procedure.
• Left ventricular ejection fraction < 30%.
• Recent PCI within 72 hours, or PCI within the past 30 days with a major adverse cardiac event.
• Known allergy or contraindication to study-related medications or materials (aspirin, heparin, P2Y12 inhibitors, stainless steel, cobalt chromium, contrast media) not manageable with premedication.
• Significant blood count abnormalities (platelets < 100,000/mm³ or > 700,000/mm³; WBC < 3,000/mm³).
• Severe renal impairment (serum creatinine > 2.0 mg/dL or eGFR < 30 mL/min).
• Stroke within 30 days before the procedure.
• Hemodynamic instability or acute pulmonary edema.
• Significant active bleeding or high bleeding risk (recent GI bleeding, bleeding disorders, refusal of transfusion).
• Pregnancy, breastfeeding, or planning pregnancy before study completion.
• Current participation in another investigational study without completed follow-up.
• Angiographic exclusions: total occlusion, intraluminal thrombus, need for atherectomy or other non-balloon devices before stenting, unprotected left main stenosis > 50%, or certain bypass graft lesions.