CArotid Robotic Procedure Evaluation (CARE)

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

Study Overview

• Status: Completed
• Conditions: Carotid Artery Diseases
• Intervention / Treatment: Device: Carotid Artery Stenting

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 Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

• Study Contact: Name: Christophe LE ROUX, MSc; Phone Number: +33 (0)760278098; Email: cleroux@cerc-europe.org
• Study Contact Backup: Name: Clémentine LIARD, Eng; Phone Number: +33 (0)762060410; Email: clementine.liard@robocath.com

Study Locations

• France
  • Rennes, France, 35000
    • Hopital Pontchaillou - CHU Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Up to 8 Patients with carotid artery disease, including patients with web diaphragm, who qualify for Carotid Artery Stenting.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure technical success	Absence of any unplanned manual assistance or conversion to manual CAS for procedural completion	Index Procedure : Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Radiation exposure for the patient	Dose measured by the imaging system during the procedure.	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.	Index Procedure : At Day 0
Overall contrast volume	Total volume of contrast (mL) used during the procedure.	Index Procedure : At Day 0
Contrast volume during Robotic Procedure	Total volume of contrast (mL) used during the robotic procedure.	Index Procedure : At Day 0

Collaborators and Investigators

• Sponsor: Robocath
• Collaborators: European Cardiovascular Research Center
• Investigators: Principal Investigator: François EUGENE, MD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carotid Artery Diseases
• Other Study ID Numbers: ROB-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No