Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05853419
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2023-02-28
Brief Title:
Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
Sponsor:
Robocath
Organization:
Robocath
Study Overview
Official Title:
Change History and Adopt a Robotic SolutioN for anGioplasty procedurE
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHANGE
Brief 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 stentballoon 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 operators commands
This study is a single-arm open-label multi-center registry
The CHANGE registry part of the ROBOCATHs 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
This study is a single-arm open-label multi-center registry
The CHANGE registry part of the ROBOCATHs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None