coronary artery disease
Conditions
Interventions
None listed
Sponsors
Robocath
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age *18 years; 2. Candidate for PCI; 3. Presence of a de novo coronary artery stenosis of * 50% and
Exclusion criteria
Exclusion criteria: Subject will not be included if any one of the following conditions exists: 1. Target lesion has TIMI flow 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 only); 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 evaluated; 14. Pregnant and breastfeeding women or intention to become pregnant prior to completion of all follow-up procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-Primary Endpoints: Safety Endpoint: 1. For R-One performed PCI, absence of intra-procedural complications defined as coronary dissection * NHLBI type D, perforation, decrease of TIMI flow (*2), acute occlusion, visible thrombus formation, significant air embolus during the procedure, traumatic aortic or left main dissection by guiding catheter. Efficacy Endpoint: 2. 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 |
|---|---|
| Secondary Endpoints: * Individual components of the co-primary endpoints * Procedure duration * Robot duration * Radiation exposure for the patient * Radiation exposure for the operator * Contrast volume * Bleeding or vascular complications at discharge * Device Oriented composite criteria (ARC 2 definition) defined as cardiovascular death, myocardial infarction (periprocedural and spontaneous) non-clearly attributed to a non-target or clinically driven target lesion revascularization - At hospital discharge - At 30 days (defined as cardiovascular death, MI and target lesion revascularization) | — |
Countries
Netherlands
Outcome results
None listed