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By invitation only

The Efficacy and Safety Evaluation of 5G Tele-PCI Using R-OneTM

NCT07132255 · Cathbot (Shanghai) Robot Co., Ltd · Updated 20 Aug 2025

What is being tested
R-One assisted tele-PCI; R-One assisted on-site PCI
For
Coronary Artery Disease (CAD); Percutaneous Coronary Intervention (PCI)
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 80 years. About 60 people. The full rules are on the registry page.
Where
China (5 sites)
When
Starts or started 14 March 2024, ends 30 Sept 2026. Registered 20 Aug 2025.
Results
None posted yet.

In the researchers' words

Patients with coronary artery disease requiring PCI treatment were enrolled in the study. All patients underwent PCI with the robotic R-OneTM System (R-One Vascular Robotics, Cathbot). The system was designed for coronary PCI and consists of 2 major components: the command unit and a bedside robot. The command unit is a radiation-shielded, mobile workstation that was positioned in the corner of the catheterization laboratory. The interventional cardiologist sits at the command unit and remotely performs the PCI using the console joysticks. Commands from the control console are delivered as electrical signals along a communication cable that runs from the control console to the robotic drive, on which a sterile cassette is placed. The cassette, which is loaded with the robot and connected to the guiding catheters, imposes axial and rotational forces on the intracoronary devices. Fluoro-scopic, electrocardiographic, and hemodynamic images are "slaved" to the duplicate monitors inside the cockpit, enabling visualization from a closer distance. After completion of diagnostic angiography, the guiding catheter was positioned at the ostium of the coronary artery and connected to the disposable cassette on the robotic drive. The guidewire was loaded into the cassette before starting the robotic-enhanced PCI. The treatment plan is decided by the doctor according to the patients'…
ClinicalTrials.gov, NCT07132255

Sites

  • Jimsar People's HospitalJimsar, Xinjiang Uygur Autonomous Region, China
  • Karamay Central Hospital of XinjiangKaramay, Xinjiang Uygur Autonomous Region, China
  • The First Hospital of Kashgar PrefectureKashgar, Xinjiang Uygur Autonomous Region, China
  • Luopu People's HospitalLuopu, Xinjiang Uygur Autonomous Region, China
  • People's Hospital of Xinjiang Uygur Autonomous RegionÜrümqi, Xinjiang Uygur Autonomous Region, China