R-One Efficiency For PCI Evolution with robotic assistance - R-evolution

Robocath0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月15日

试验速览

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•1. Age *18 years;
•2. Candidate for PCI;
•3. Presence of a de novo coronary artery stenosis of * 50% and <100% in a
•native coronary artery indicated and suitable for stent implantation;
•4. The vessel has a reference vessel diameter ranging from 2.5 mm to 4.0 mm;
•5. The target lesion length allows for treatment with a single stent up to 38
•mm in length;
•6. 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);
•7. 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.
•Patients with complex coronary artery disease may be considered for the study.
•Complex lesions such as defined below which are to be treated with PCI should
•be successfully treated before the target lesion (s) in a different procedure.

•Subject will not be included if any one of the following conditions exists:
•1. Target lesion has TIMI flow < 3;
•2. Treatment of in-stent restenosis, or prior stent in the target vessel
•proximal to the target lesion;
•3. More than one target lesion per vessel requiring treatment at the time of
•4. 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
•5. Target lesion is located in left main coronary artery, or any left main
•stenosis > 30%;
•6. Target lesion is within 5 mm of the ostial LAD, ostial LCX or ostial RCA;
•7. Severe vessel tortuosity;
•8. Severe vessel calcification;
•9. STEMI, cardiopulmonary resuscitation or cardiogenic shock within 48 hours of
•the procedure;
•10. Presence of visible thrombus;
•11. Need for any procedure other than balloon angioplasty or stenting (e.g.
•atherectomy, laser, are excluded);
•12. Patients under judicial protection, tutorship or curatorship (for France
•13. Any patient participating in another clinical study evaluating a drug or a
•medical device (except registries for which the primary endpoint has not been
•14. Pregnant and breastfeeding women or intention to become pregnant prior to
•completion of all follow-up procedures.

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