CArotid Robotic Procedure Evaluation

NCT ID: NCT05093127

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-16
• Study Completion Date: 2022-11-15

Brief Summary

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.

Conditions

Carotid Artery Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Cardiovascular Research Center

NETWORK

Sponsor Role: collaborator

Robocath

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François EUGENE, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Hôpital Pontchaillou - CHU Rennes

Rennes, , France

Countries

France

Other Identifiers

ROB-02

Identifier Type: -

Identifier Source: org_study_id