Hôpital Pontchaillou - CHU Rennes
Rennes, 35000, France
NCT Number: NCT05093127
This study aims to evaluate the use of R-One in the peripheral vasculature.
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Notify Me18 year and older
All sexes
Observational
Rennes, 35000, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Index Procedure : Day 0
Absence of any unplanned manual assistance or conversion to manual CAS for procedural completion
Time frame: At Day 0 and at Day 30 +/- 7 days
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.
Time frame: Index Procedure : At Day 0
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).
Time frame: Index Procedure: At Day 0
Dose measured by the imaging system during the procedure.
Time frame: Index Procedure : At Day 0
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Time frame: Index Procedure : At Day 0
Total volume of contrast (mL) used during the procedure.
Time frame: Index Procedure : At Day 0
Total volume of contrast (mL) used during the robotic procedure.
Robocath
Industry
Acronym: CARE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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