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| Name | Class |
|---|---|
| European Cardiovascular Research Center | NETWORK |
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This study aims to evaluate the use of R-One in the peripheral vasculature.
This is a prospective, single-arm, monocenter study to evaluate the R-one use in carotid artery stenting procedures. Up to 8 patients will be included and followed at 30 days.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid Artery Stenting | Device | R-OneTM system is a tool available to physicians for performing CAS without changing the treatment of the pathology. R-OneTM system is designed to remotely deliver and manipulate guidewires and stent/balloon devices during Carotid Artery Stenting. The system is composed of the R-OneTM robotic platform used in combination with two accessories, the Mobile radioprotection screen and a sterile and single-use R-OneTM consumable kit. The physician, seated at the remote radio-protected control station, manipulates guidewires and/or balloon/stent catheters using joysticks on the Command unit. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure technical success | Absence of any unplanned manual assistance or conversion to manual CAS for procedural completion | Index Procedure : Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of intra-procedural complications | Absence of major stroke which required intracranial mechanical thrombectomy or IV-thrombolysis, perforation of carotid artery, acute occlusion of carotid artery or significant thrombus formation, significant air embolus during the procedure. | At Day 0 and at Day 30 +/- 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 8 Patients with carotid artery disease, including patients with web diaphragm, who qualify for Carotid Artery Stenting.
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| Name | Affiliation | Role |
|---|---|---|
| François EUGENE, MD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pontchaillou - CHU Rennes | Rennes | 35000 | France |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Reduction in primary operator radiation exposure |
Reduction of Primary Operator Radiation Exposure measured by dedicated dosimeters, defined as the ratio of the radiation dose measured at the primary operator during the overall procedure to the radiation exposure measured at the procedure table (the conventional site of the primary operator during the procedure). |
| Index Procedure : At Day 0 |
| Radiation exposure for the patient | Dose measured by the imaging system during the procedure. | Index Procedure: At Day 0 |
| Overall Procedure Time | Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. | Index Procedure : At Day 0 |
| Overall contrast volume | Total volume of contrast (mL) used during the procedure. | Index Procedure : At Day 0 |
| Contrast volume during Robotic Procedure | Total volume of contrast (mL) used during the robotic procedure. | Index Procedure : At Day 0 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |