NCT05853419

Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Robocath · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The R-One system is a class "IIb" CE marked medical device designed to remote deliver and manipulate coronary guidewires and stent/balloon devices during Percutaneous Coronary Intervention (PCI). The system comprises the R-One Robotic Platform used in combination with two accessories, the Mobile Radioprotection Screen and a sterile and single-use R-One Consumable Kit. The R-One is not autonomous and operates only under the operator's commands. This study is a single-arm, open-label, multi-center registry. The CHANGE registry, part of the ROBOCATH's post-market clinical follow-up activities, is a real world study aiming to confirm the safety and performance, including the clinical benefit, of the R-One robotic systems medical device. 500 patients with coronary artery disease and with clinical indication for PCI will be recruited in up to Up to 15 centers distributed in Europe and South Africa.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-20
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2023-05-10
• Last updated: 2025-08-20

Locations

8 sites across 6 countries: Belgium, France, Germany, Italy, Poland, South Africa