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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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-11-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

vascular interventional robotic system

Patients all undergoing PCI with vascular interventional robotic system

DEVICE

human operator

Patients undergoing PCI by human operators

Sponsors & Collaborators

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07233317 on ClinicalTrials.gov