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Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

NCT05853419 · Robocath · Updated 20 Aug 2025

What is being tested
Robotic-assisted PCI
For
Coronary Disease
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 120 years. About 500 people. The full rules are on the registry page.
Where
Belgium, France, Germany, Italy, Poland, South Africa (8 sites)
When
Starts or started 20 June 2023, ends June 2026. Registered 10 May 2023.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT05853419

Sites

  • Het Ziekenhuisnetwerk Antwerpen vzwAntwerp, Belgium
  • Brest university hospitalBrest, Brittany Region, France
  • Rouen university hospitalRouen, France
  • Centre Cardiologique du NordSaint-Denis, Île-de-France Region, France
  • Rheinland Klinikum Neuss GmbHNeuss, Lukaskrankenhaus, Germany
  • San Donato Policlinco KardiaSan Donato Milanese, MI, Italy
  • Polskie Towarzystwo KardiologiczneWarsaw, Par Défaut, Poland
  • Netcare Christiaan Barnard Memorial HospitalCape Town, le Cap, South Africa