Carotid Artery DiseasesCARENCT05093127
CArotid Robotic Procedure Evaluation
An observational study of Carotid Artery Diseases, run by Robocath at 1 site in France.
Trial summary
This study aims to evaluate the use of R-One in the peripheral vasculature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Diseases
- What is being tested?
- Carotid Artery Stenting
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2021to 15 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 8 Patients with carotid artery disease, including patients with web diaphragm, who qualify for Carotid Artery Stenting.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the use of R-One in the peripheral vasculature.
Read the detailed description
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.
- Conditions
- Carotid Artery Diseases
- Being tested
- Carotid Artery Stenting
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Artery StentingDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure technical success
Absence of any unplanned manual assistance or conversion to manual CAS for procedural completion
Measured: Index Procedure : Day 0
Secondary outcomes (6)
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.
Measured: At Day 0 and at Day 30 +/- 7 days
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).
Measured: Index Procedure : At Day 0
Radiation exposure for the patient
Dose measured by the imaging system during the procedure.
Measured: 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.
Measured: Index Procedure : At Day 0
Overall contrast volume
Total volume of contrast (mL) used during the procedure.
Measured: Index Procedure : At Day 0
Contrast volume during Robotic Procedure
Total volume of contrast (mL) used during the robotic procedure.
Measured: Index Procedure : At Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start16 Nov 2021
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robocath
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Responsible party
- Sponsor
- Investigators
- François EUGENE, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093127
- Sponsor's protocol ID
- ROB-02
- Acronym
- CARE
- Status last verified
- May 2023
- First submitted
- 30 Sep 2021
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CArotid Robotic Procedure Evaluation
- ClinicalTrials.gov ID
- NCT05093127
- Acronym / sponsor ID
- CARE / ROB-02
- Conditions
- Carotid Artery Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- RobocathIndustry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the use of R-One in the peripheral vasculature.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 8 Patients with carotid artery disease, including patients with web diaphragm, who qualify for Carotid Artery Stenting.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid Artery StentingR-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. | Device | – |
Primary outcome
Procedure technical success
Time frame: Index Procedure : Day 0
Absence of any unplanned manual assistance or conversion to manual CAS for procedural completion
6 secondary outcomes
Absence of intra-procedural complications
Time frame: At Day 0 and at Day 30 +/- 7 days
Reduction in primary operator radiation exposure
Time frame: Index Procedure : At Day 0
Radiation exposure for the patient
Time frame: Index Procedure: At Day 0
Overall Procedure Time
Time frame: Index Procedure : At Day 0
Overall contrast volume
Time frame: Index Procedure : At Day 0
Contrast volume during Robotic Procedure
Time frame: Index Procedure : At Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François EUGENE, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Diseases, run by Robocath at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure technical success (time frame: Index Procedure : Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.