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
153 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
The main objective of the CHANGE registry is the evaluation of the real-world performance and safety profile of the R-One System in PCI.
CONDITIONS
Official 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
- Diagnosed with coronary artery disease and clinically indicated for PCI
- Considered appropriate for robotic-assisted PCI by the investigator
- 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
- Current ST-segment elevation myocardial infarction (STEMI)
- 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
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
CONTACT
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here