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RECRUITING
NCT05853419

Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

Sponsor: Robocath

View on ClinicalTrials.gov

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

Interventions

DEVICE

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