CArotid Robotic Procedure Evaluation

NCT05093127 | Completed DMC

• 1 other identifier: ROB-02
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carotid Artery Diseases

Outcome Measures

Primary Outcomes (1)

• Procedure technical success

  Absence of any unplanned manual assistance or conversion to manual CAS for procedural completion

  Index Procedure : Day 0

Secondary Outcomes (6)

• Absence of intra-procedural complications

  At Day 0 and at Day 30 +/- 7 days

• Reduction in primary operator radiation exposure

  Index Procedure : At Day 0

• Radiation exposure for the patient

  Index Procedure: At Day 0

• Overall Procedure Time

  Index Procedure : At Day 0

• Overall contrast volume

  Index Procedure : At Day 0

Interventions

Carotid Artery Stenting DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years;
• Candidate for CAS
• Presence of a WEB-diaphragm lesion at carotid artery ostium, proved by non-invasive imaging (CTA or MRA)
• No minimum delay between previous stroke therapy (IMT) is required
• Double antiplatelet therapy the day before the procedure and 1 month after the procedure is required
• 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.
• The patient is affiliated with a social security scheme

You may not qualify if:

• Target lesion has atherosclerotic or dissection stenosis or occlusion;
• Treatment of in-stent restenosis, or prior stent in the target vessel proximal to the target lesion;
• CAS performed at the end of intracranial mechanical thrombectomy
• Contra-indications of double antiplatelet therapy the day before the procedure and 1 month after the procedure
• Patients under judicial protection, tutorship or curatorship
• 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);
• Pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures.

Sponsors & Collaborators

• Robocath: lead
• European Cardiovascular Research Center: collaborator

Study Sites (1)

Hôpital Pontchaillou - CHU Rennes

Rennes, 35000, France

Location

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• François EUGENE, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 26, 2021
• Study Start: November 16, 2021
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

FR (1)