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OpenTrials
Completed

NCT Number: NCT05093127

CArotid Robotic Procedure Evaluation

This study aims to evaluate the use of R-One in the peripheral vasculature.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pontchaillou - CHU Rennes

Rennes, 35000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years;
  • Candidate for CAS
  • Presence of a WEB-diaphragm lesion at carotid artery ostium, proved by non-invasive imaging (CTA or MRA)
  • No minimum delay between previous stroke therapy (IMT) is required
  • Double antiplatelet therapy the day before the procedure and 1 month after the procedure is required
  • 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.
  • The patient is affiliated with a social security scheme

Exclusion criteria

  • Target lesion has atherosclerotic or dissection stenosis or occlusion;
  • Treatment of in-stent restenosis, or prior stent in the target vessel proximal to the target lesion;
  • CAS performed at the end of intracranial mechanical thrombectomy
  • Contra-indications of double antiplatelet therapy the day before the procedure and 1 month after the procedure
  • Patients under judicial protection, tutorship or curatorship
  • Any patient participating in another clinical study valuating 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.

Treatment and study plan

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.

Primary outcomes

  1. Procedure technical success

    Time frame: Index Procedure : Day 0

    Absence of any unplanned manual assistance or conversion to manual CAS for procedural completion

Secondary outcomes

  1. Absence of intra-procedural complications

    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.

  2. Reduction in primary operator radiation exposure

    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).

  3. Radiation exposure for the patient

    Time frame: Index Procedure: At Day 0

    Dose measured by the imaging system during the procedure.

  4. Overall Procedure Time

    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.

  5. Overall contrast volume

    Time frame: Index Procedure : At Day 0

    Total volume of contrast (mL) used during the procedure.

  6. Contrast volume during Robotic Procedure

    Time frame: Index Procedure : At Day 0

    Total volume of contrast (mL) used during the robotic procedure.

Sponsors and collaborators

Lead sponsor

Robocath

Industry

Collaborators

  • European Cardiovascular Research Center

Registry information

Acronym: CARE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2021
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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