R-One Efficiency For PCI Evolution With Robotic Assistance

Study Overview
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Brief Summary
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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.

Official Title
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R-One Efficiency For PCI Evolution With Robotic Assistance

Conditions
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Coronary Artery Disease, Percutaneous Coronary Intervention

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention
* Device: Percutaneous Coronary Intervention using R-One assistance


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R-One<br>Patients treated with robotic assistance | Procedure: Percutaneous Coronary Intervention<br>* PCI with robotic assistance<br>Device: Percutaneous Coronary Intervention using R-One assistance<br>* PCI with robotic assistance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Endpoint: Number of patients with absence of Intra-procedural complications (Dissection, Thrombus, Air embolus, traumatic aorta) | Absence of Intra-procedural complications (Dissection >/= NHLBI type D, perforation, decrease of TIMI flow (</= 2), acute occlusion, visible thrombus formation, significant air embolus, traumatic aortic or Left Main dissection by guiding catheter | Peri-procedure | 
| Efficacy Endpoint: Number of Patients with Procedure technical success | Procedure technical success defined as the successful advancement and retraction of all PCI devices (guidewires, balloon catheters and stents) and the successful treatment of all the target lesions using the R-One system and without conversion to manual operation | During Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Absence of each type of Intra-procedural complication (Dissection, Thrombus, Air embolus, traumatic aorta) | Component of the Primary Safety Endpoint: Absence of Intra-procedural complications (Dissection >/= NHLBI type D, perforation, decrease of TIMI flow (</= 2), acute occlusion, visible thrombus formation, significant air embolus, traumatic aortic or Left Main dissection by guiding catheter | During Procedure | 
| Procedure duration | Time between arterial sheath introduction and sheath removal | During Procedure | 
| Robot duration | From the time when the robot begins to manipulate the guidewire to the time when the last guidewire is removed | During Procedure | 
| Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose) | Patient and Operator | During Procedure | 
| Contrast Volume in mL | Measure of the volume of injected contrast media | During Procedure | 
| Rate of Bleeding or Vascular Complications | BARC definition | Up to 1 month | 
| Rate of Device Oriented Composite Criteria (Cardiovascular Death, Myocardial Infarction (peri-procedural and spontaneous), non clearly attributed to a non target or clinically driven target lesion revascularization) | ARC 2 definition: Cardiovascular Death, Myocardial Infarction (peri-procedural and spontaneous), non clearly attributed to a non target or clinically driven target lesion revascularization | Post-Procedure, 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Percutaneous Coronary Intervention