Coronary Artery Disease, Percutaneous Coronary Intervention
Conditions
Keywords
Coronary Artery Disease, Percutaneous Coronary Intervention
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.
Interventions
PROCEDUREPercutaneous Coronary Intervention
PCI with robotic assistance
DEVICEPercutaneous Coronary Intervention using R-One assistance
PCI with robotic assistance
Sponsors
Robocath
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Rate of Bleeding or Vascular Complications | Up to 1 month | BARC definition |
| 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 |
| Contrast Volume in mL | During Procedure | Measure of the volume of injected contrast media |
| Procedure duration | During Procedure | Time between arterial sheath introduction and sheath removal |
Countries
Belgium, France, Luxembourg, Netherlands
Outcome results
None listed