R-One Efficiency For PCI Evolution With Robotic Assistance

R-One Efficiency For PCI Evolution With Robotic Assistance

This study is a Prospective, Multi-center, Single-arm clinical study, in patients with Coronary Artery Disease, including patients with silent ischemia (excluding STEMI), who qualify for elective Percutaneous Coronary Intervention (PCI), aimed to assess the Safety and Efficacy of the R-One device in elective PCI.

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.