R-One Efficiency For PCI Evolution With Robotic Assistance

Inclusion criteria

• Age ≥18 years;
• Candidate for PCI;
• Presence of a de novo coronary artery stenosis of ≥ 50% and <100% in a native coronary artery indicated and suitable for stent implantation;
• The vessel has a reference vessel diameter ranging from 2.5 mm to 4.0 mm;
• The target lesion length allows for treatment with a single stent up to 38 mm in length;
• Up to 2 target vessels each with a single target lesion requiring a single stent per lesion and treatable within a single procedure may be included (no further staged procedure allowed);
• The patient provides written informed consent as approved by the applicable Ethics Committee and is willing to comply with all study requirements including 30 days follow-up.

Exclusion criteria

• Target lesion has TIMI flow < 3;
• Treatment of in-stent restenosis, or prior stent in the target vessel proximal to the target lesion;
• More than one target lesion per vessel requiring treatment at the time of procedure;
• Target lesion is a bifurcation requiring balloon or stent implantation of the side branch, with a side-branch RVD of ≥1.5 mm with a DS ≥50% at or within 5 mm its origin, or RVD ≥2.0 mm regardless of the presence of side branch disease;
• Target lesion is located in left main coronary artery, or any left main stenosis > 30%;
• Target lesion is within 5 mm of the ostial LAD, ostial LCX or ostial RCA;
• Severe vessel tortuosity;
• Severe vessel calcification;
• STEMI, cardiopulmonary resuscitation or cardiogenic shock within 48 hours of the procedure;
• Presence of visible thrombus;
• Need for any procedure other than balloon angioplasty or stenting (e.g. atherectomy, laser, are excluded);
• Patients under judicial protection, tutorship or curatorship (for France only);
• Any patient participating in another clinical study evaluating a drug or a medical device (except registries for which the primary endpoint has not been evaluated;
• Pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures.