CArotid Robotic Procedure Evaluation (CARE)

Robocath

Status: Completed

Conditions: Carotid Artery Diseases

Treatments: Device: Carotid Artery Stenting

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT05093127

ROB-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.