CArotid Robotic Procedure Evaluation

Carotid Artery Diseases Clinical Trial

— CARE  

Official title:

CArotid Robotic Procedure Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05093127
• Other study ID #: ROB-02
• Status: Completed
• Start date: November 16, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: May 2023
• Source: Robocath
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years;

2. Candidate for CAS

3. Presence of a WEB-diaphragm lesion at carotid artery ostium, proved by non-invasive imaging (CTA or MRA)

4. No minimum delay between previous stroke therapy (IMT) is required

5. Double antiplatelet therapy the day before the procedure and 1 month after the procedure is required

6. 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.

7. The patient is affiliated with a social security scheme

Exclusion Criteria:

1. Target lesion has atherosclerotic or dissection stenosis or occlusion;

2. Treatment of in-stent restenosis, or prior stent in the target vessel proximal to the target lesion;

3. CAS performed at the end of intracranial mechanical thrombectomy

4. Contra-indications of double antiplatelet therapy the day before the procedure and 1 month after the procedure

5. Patients under judicial protection, tutorship or curatorship

6. 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);

7. Pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures.

Related Conditions & MeSH terms

• Carotid Artery Diseases

Intervention

Device:
• Carotid Artery Stenting
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.

Locations

Country	Name	City	State
France	Hôpital Pontchaillou - CHU Rennes	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Robocath	European Cardiovascular Research Center

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure technical success	Absence of any unplanned manual assistance or conversion to manual CAS for procedural completion	Index Procedure : Day 0
Secondary	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
Secondary	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
Secondary	Radiation exposure for the patient	Dose measured by the imaging system during the procedure.	Index Procedure: At Day 0
Secondary	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
Secondary	Overall contrast volume	Total volume of contrast (mL) used during the procedure.	Index Procedure : At Day 0
Secondary	Contrast volume during Robotic Procedure	Total volume of contrast (mL) used during the robotic procedure.	Index Procedure : At Day 0