Clinical Research Directory

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.