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Not recruiting yet

Evaluating the Safety and Effectiveness of a Vascular Interventional Robotic System in Assisting With Percutaneous Coronary Intervention Procedures: A Prospective, Multicenter, Randomized Controlled Clinical Trial

NCT07233317 · China National Center for Cardiovascular Diseases · Updated 18 Nov 2025

What is being tested
vascular interventional robotic system; human operator
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 to 80 years. About 170 people. The full rules are on the registry page.
Where
China
When
Starts or started 1 Dec 2025, ends 30 June 2026. Registered 18 Nov 2025.
Results
None posted yet.

In the researchers' words

The goal of this clinical trial is to verify the safety and effectiveness of the vascular interventional robotic system developed and manufactured by Beijing Zhongke Hongtai Medical Technology Co., Ltd. in assisting percutaneous coronary intervention procedures in patients with coronary artery disease. The main question it aims to answer is: 1. Whether the PCI-assisted procedure was clinically successful and technically successful? 2. Will the PCI-assisted procedure can reduce procedure time, PCI time, and radiation exposure for both operators and patients?? Researchers will compare the vascular interventional robotic system with human operators to see if using the vascular interventional robotic system in PCI procedure is effective and safe. Participants will undergo percutaneous coronary interventions with the vascular interventional robotic system or human operator based on the randomization results. Then all participants will receive a 1-month follow up to evaluate the primary and secondary endpoints.
ClinicalTrials.gov, NCT07233317

Sites

  • Fuwai Hospital, Chinese Academy of Medical SciencesBeijing, Xicheng District, China