Clinical Trial

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

Study acronym: R-STAR-FIH
Not Yet Recruiting
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Record status
This record was last updated August 28, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07146204
Lead Sponsor Robocath
Collaborators: Veranex Switzerland SA
Conditions Coronary Artery Disease
Enrollment 20 participants
Start Date 2026-01
Primary Completion 2026-02 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2025-08-28