Actively Recruiting
Change History and Adopt a Robotic Solution for Angioplasty Procedure
Led by Robocath · Updated on 2025-08-20
500
Participants Needed
8
Research Sites
4 weeks
Total Duration
On this page
Sponsors
R
Robocath
Lead Sponsor
E
European Cardiovascular Research Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the real-world performance and safety of the R-One System, a robotic device designed to assist in Percutaneous Coronary Intervention (PCI) for patients with coronary artery disease. This single-arm, open-label, multi-center registry aims to confirm the safety, performance, and clinical benefit of the R-One system across up to 15 centers in Europe and South Africa. The study will include 500 adult patients with clinical indications for PCI. Participants will undergo robotic-assisted PCI using the R-One system, which remotely delivers and manipulates coronary guidewires and stent or balloon devices under the operator's control. The system includes the R-One Robotic Platform, a Mobile Radioprotection Screen, and a sterile, single-use consumable kit. Procedures will follow routine hospital practices, current guidelines, and manufacturer instructions. During the study, researchers will assess clinical and technical success of PCI from day 0 to day 3 and during the procedure. They will also monitor radiation exposure to patients and operators, procedure time, contrast volume, fluoroscopy time, and any safety events occurring up to three days post-procedure. Participation involves monitoring during and shortly after PCI to evaluate outcomes and safety.
CONDITIONS
Brief Title
Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of coronary artery disease with clinical indication for PCI
- Deemed appropriate for robotic-assisted PCI
- Provided written informed consent after being informed about the study
You will not qualify if you...
- Unable or unwilling to provide informed consent, unless waived by ethics committee
- Investigator determines subject or coronary anatomy unsuitable for robotic-assisted PCI
- Presence of STEMI
- Presence of cardiogenic shock
- Under judicial protection, guardianship, curatorship, or deprived of liberty by judicial or administrative decision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants undergo robotic-assisted percutaneous coronary intervention (PCI) performed according to routine hospital practices and current scientific guidelines using the R-One robotic system.
1 procedure visit (in-person)
Duration - Up to 3 days
Participants are observed for safety and clinical outcomes following the robotic-assisted PCI procedure.
Follow-up visits during hospital stay or up to 3 days post-procedure
Trial Site Locations
Total: 8 locations
1
Het Ziekenhuisnetwerk Antwerpen vzw
Antwerp, Belgium, 2000
Actively Recruiting
2
Brest university hospital
Brest, Brittany Region, France, 29609
Actively Recruiting
3
Rouen university hospital
Rouen, France, 76000
Actively Recruiting
4
Centre Cardiologique du Nord
Saint-Denis, Île-de-France Region, France, 93200
Actively Recruiting
5
Rheinland Klinikum Neuss GmbH
Neuss, Lukaskrankenhaus, Germany, 41464
Actively Recruiting
6
San Donato Policlinco Kardia
San Donato Milanese, MI, Italy, 20097
Not Yet Recruiting
7
Polskie Towarzystwo Kardiologiczne
Warsaw, Par Défaut, Poland, 02-507
Not Yet Recruiting
8
Netcare Christiaan Barnard Memorial Hospital
Cape Town, le Cap, South Africa, 8001
Not Yet Recruiting
Research Team
H
Hamouda Abassi, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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