CArotid Robotic Procedure Evaluation

Completed

• Conditions: Carotid Artery Diseases

• Registration Number: NCT05093127
• Lead Sponsor: Robocath

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.

Study Timeline

• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-10-26
• Study Start: 2021-11-16
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procedure technical success	Index Procedure : Day 0	Absence of any unplanned manual assistance or conversion to manual CAS for procedural completion

Secondary Outcome Measures

Name	Time	Method
Radiation exposure for the patient	Index Procedure: At Day 0	Dose measured by the imaging system during the procedure.
Overall Procedure Time	Index Procedure : At Day 0	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Overall contrast volume	Index Procedure : At Day 0	Total volume of contrast (mL) used during the procedure.
Contrast volume during Robotic Procedure	Index Procedure : At Day 0	Total volume of contrast (mL) used during the robotic procedure.
Absence of intra-procedural complications	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.
Reduction in primary operator radiation exposure	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).

Trial Locations

Locations (1)

Hôpital Pontchaillou - CHU Rennes; 🇫🇷 Rennes, France