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First in Human Trial of R-Star: A Novel Robotic System for Minimally Invasive Coronary Artery Procedures.
NCT07146204 · Robocath · Updated 28 Aug 2025
- What is being tested
- Robotic-assisted percutaneous coronary intervention
- For
- Coronary Artery Disease
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 20 people. The full rules are on the registry page.
- Where
- France
- When
- Starts or started Jan 2026, ends Feb 2026. Registered 28 Aug 2025.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Centre cardiologique du nordSaint-Denis, France
