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

Prior treatment

• Stroke within 30 days before the procedure.

Other illness

• Acute myocardial infarction within 72 hours before the study procedure.
• 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 active bleeding or high bleeding risk (recent GI bleeding, bleeding disorders, refusal of transfusion).

Lab values

• Left ventricular ejection fraction \< 30%.
• 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).

Other

• Planned PCI or coronary artery bypass graft (CABG) within 30 days after the study procedure.
• Hemodynamic instability or acute pulmonary edema.
• 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.

• 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.