Clinical trials

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Condition / disease
Location
Status: Not yet recruiting

First in Human Trial of R-Star: A Novel Robotic System for Minimally Invasive Coronary Artery Procedures.

The goal of this clinical trial is to learn if the R-Star robotic system can be used safely and effectively to perform percutaneous coronary intervention (PCI) in adults with coronary artery disease who are scheduled for an elective PCI. The main questions it aims to answer are: * Can PCI be completed with the robotic system without needing to switch fully to manual operation because of a technical issue or system limitation? * Is the treated artery adequately opened without complications during the procedure? Participants will: * Have selection tests, including a medical exam, lab tests, ECG, and a review of their medical history. * Undergo PCI using the R-Star robotic system, with angiography before and after the procedure. * Have checkups before leaving the hospital and about 30 days later to monitor recovery and collect study data.

Participants needed: 20
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: RobocathUpdated: Aug 28, 2025Locations: 1
Eligibility criteria

Patient ≥ 18 years old; [+8]

Planned PCI or coronary artery bypass graft (CABG) within 30 days after the stud... [+12]

Status: Recruiting

Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

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.

Participants needed: 500
Trial details
Age: 18-120Biological sex: AllType: ObservationalSponsor: RobocathUpdated: Aug 20, 2025Locations: 8Duration: 1 Day
Eligibility criteria

1. Age ≥ 18 years; [+3]

1.Failure/inability/unwillingness to provide informed consent, unless the ethic... [+4]