R-ONE® Robotically-Enhanced PCI Intervention Study

NACompletedINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

November 23, 2021

Primary Completion Date

May 26, 2022

Study Completion Date

June 20, 2022

Conditions
Cardiovascular Diseases
Interventions
DEVICE

R-One vascular interventional navigation control system

"The interventional cardiologist sits at the cockpit and remotely performs the PCI using the console joysticks. The cassette, which is loaded with the interventional devices and connected to the guiding catheters, imposes axial and rotational forces on the intracoronary devices. Fluoroscopic, 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. Treatment was administrated according to local site protocols. Pre and post dilation was done per operator discretion. All intracoronary devices were to be manipulated exclusively by the robotic system, with bailout to manual conversion when needed."

Trial Locations (4)

100853

Chinese PLA General Hospital, Beijing

514031

Meizhou People's Hospital, Meizhou

830001

People's Hospital of Xinjiang Uygur Autonomous Region, Ürümqi

030024

Shanxi Cardiovascular Hospital, Taiyuan

All Listed Sponsors
collaborator

Chinese PLA General Hospital

OTHER

collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

collaborator

Shanxi Cardiovascular Hospital

OTHER

collaborator

Meizhou People's Hospital

OTHER

collaborator

Peking University

OTHER

lead

Cathbot (Shanghai) Robot Co., Ltd

INDUSTRY

NCT07135557 - R-ONE® Robotically-Enhanced PCI Intervention Study | Biotech Hunter | Biotech Hunter