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Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
Sponsor: Robocath
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 120 Years
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2023-06-20
Completion Date
2026-06
Last Updated
2025-08-20
Healthy Volunteers
No
Conditions
Interventions
Robotic-assisted PCI
Robotic-assisted PCI will be performed according to the routine hospital practices, current scientific guidelines and following Instructions for Use (IFU) provided by the manufacturer
Locations (8)
Het Ziekenhuisnetwerk Antwerpen vzw
Antwerp, Belgium
Brest university hospital
Brest, Brittany Region, France
Rouen university hospital
Rouen, France
Centre Cardiologique du Nord
Saint-Denis, Île-de-France Region, France
Rheinland Klinikum Neuss GmbH
Neuss, Lukaskrankenhaus, Germany
San Donato Policlinco Kardia
San Donato Milanese, MI, Italy
Polskie Towarzystwo Kardiologiczne
Warsaw, Par Défaut, Poland
Netcare Christiaan Barnard Memorial Hospital
Cape Town, le Cap, South Africa