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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
PCI with robotic assistance
PCI with robotic assistance
Het Ziekenhuisnetwerk Antwerpen vzw
Antwerp, Belgium
CHU Caen Normandie
Caen, France
CHU Rouen
Rouen, France
Clinique Pasteur
Toulouse, France
INCCI
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
Time frame: 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
Time frame: During Procedure
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
Time frame: During Procedure
Procedure duration
Time between arterial sheath introduction and sheath removal
Time frame: During Procedure
Robot duration
From the time when the robot begins to manipulate the guidewire to the time when the last guidewire is removed
Time frame: During Procedure
Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose)
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Luxembourg, Luxembourg
Maastad Ziekenhuis
Rotterdam, Netherlands
Patient and Operator
Time frame: During Procedure
Contrast Volume in mL
Measure of the volume of injected contrast media
Time frame: During Procedure
Rate of Bleeding or Vascular Complications
BARC definition
Time frame: 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
Time frame: Post-Procedure, 1 month