R-One Efficiency For PCI Evolution With Robotic Assistance

Not Applicable

Completed

• Conditions: Percutaneous Coronary Intervention; Coronary Artery Disease
• Interventions: Procedure: Percutaneous Coronary Intervention; Device: Percutaneous Coronary Intervention using R-One assistance

• Registration Number: NCT04163393
• Lead Sponsor: Robocath

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-17
• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-14
• Primary Completion: 2021-11-08
• Study Completion: 2021-12-15
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
R-One	Percutaneous Coronary Intervention using R-One assistance	Patients treated with robotic assistance
R-One	Percutaneous Coronary Intervention	Patients treated with robotic assistance

Primary Outcome Measures

Name	Time	Method
Safety Endpoint: Number of patients with absence of Intra-procedural complications (Dissection, Thrombus, Air embolus, traumatic aorta)	Peri-procedure	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
Efficacy Endpoint: Number of Patients with Procedure technical success	During Procedure	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

Secondary Outcome Measures

Name	Time	Method
Contrast Volume in mL	During Procedure	Measure of the volume of injected contrast media
Number of patients with Absence of each type of Intra-procedural complication (Dissection, Thrombus, Air embolus, traumatic aorta)	During Procedure	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
Procedure duration	During Procedure	Time between arterial sheath introduction and sheath removal
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)	Post-Procedure, 1 month	ARC 2 definition: Cardiovascular Death, Myocardial Infarction (peri-procedural and spontaneous), non clearly attributed to a non target or clinically driven target lesion revascularization
Robot duration	During Procedure	From the time when the robot begins to manipulate the guidewire to the time when the last guidewire is removed
Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose)	During Procedure	Patient and Operator
Rate of Bleeding or Vascular Complications	Up to 1 month	BARC definition

Trial Locations

Locations (6)

Het Ziekenhuisnetwerk Antwerpen vzw; 🇧🇪 Antwerpen, Belgium

Maastad Ziekenhuis; 🇳🇱 Rotterdam, Netherlands

CHU Rouen; 🇫🇷 Rouen, France

CHU Caen Normandie; 🇫🇷 Caen, France

INCCI; 🇱🇺 Luxembourg, Luxembourg

Clinique Pasteur; 🇫🇷 Toulouse, France