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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: vascular interventional robotic system; Device: human operator

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bowen Li; Phone Number: 01088396584; Email: libowen@fuwai.com

Study Locations

• China
  • Xicheng District
    • Beijing, Xicheng District, China, 100037
      • Fuwai Hospital, Chinese Academy of Medical Sciences
      • Contact: Bowen Li; Phone Number: 01088396584; Email: libowen@fuwai.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1.18 years ≤ Age ≤ 80 years; 2.Presence of clinical indications for PCI and requiring PCI treatment; 3.The subject or their legal guardian is able to understand the trial objectives, voluntarily signs the informed consent form, and is willing to comply with follow-up procedures.

4.Visual estimation of target lesion diameter stenosis ≥70% (or ≥50% with clinical evidence of myocardial ischemia); 5.2.25 mm ≤ Visual reference vessel diameter ≤ 4.0 mm; 6.The target lesion can be fully covered by a single stent, with at least 2.0 mm of normal vessel segment at the proximal and distal edges of the lesion; 7.Number of target vessels requiring treatment ≤ 2; one target lesion treated with one stent; staged treatment of the target lesion is not allowed.

Exclusion Criteria:

1. Underwent other PCI within 72 hours before the PCI procedure.
2. Underwent PCI within 30 days before the PCI procedure and experienced a Major Adverse Cardiovascular Event (MACE).
3. Experienced acute Myocardial Infarction (MI) within one week before the PCI procedure.
4. Experienced cardiogenic shock within 48 hours before the PCI procedure.
5. Had a stroke within 30 days before the PCI procedure.
6. Subjects with active peptic ulcer or upper gastrointestinal bleeding within 6 months before the PCI procedure.
7. Severe heart failure (NYHA Class IV).
8. Pregnant and lactating women, or women planning to become pregnant during the clinical trial period.
9. Known allergy to aspirin, heparin, clopidogrel, contrast agents, metal materials, etc.
10. Patients with acute or chronic kidney disease (e.g., serum creatinine >2.5 mg/dL or >221 µmol/L) or on dialysis.
11. Subjects with a history of major bleeding or coagulation disorders within the past 6 months.
12. Subjects currently participating in another clinical study that has not completed the entire follow-up period.
13. The investigator determines that the patient has other conditions unsuitable for PCI assisted by the vascular interventional robotic system.
14. Requiring other treatment modalities (such as rotational atherectomy or laser therapy) in addition to balloon angioplasty and stent angioplasty.
15. Presence of more than two lesions in a single vessel requiring simultaneous treatment.
16. Presence of visible thrombus.
17. The target lesion is located in the left main coronary artery.
18. Severely tortuous lesions, severely calcified lesions, or other complex vascular conditions deemed by the investigator as unsuitable for PCI assisted by the vascular interventional robotic system.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vascular interventional robotic system group; Undergoing PCI using the vascular interventional robotic group	Device: vascular interventional robotic system; Patients all undergoing PCI with vascular interventional robotic system
Other: human operator group; Undergoing PCI with human operators	Device: human operator; Patients undergoing PCI by human operators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Success Rate	Immediately after PCI
Technical Success Rate	Immediately after PCI

Secondary Outcome Measures

Outcome Measure	Time Frame
Total procedure time	Immediately after PCI
PCI time	Immediately after PCI
Rate of Successful Guiding Catheter Manipulation	Immediately after PCI
Patient Radiation Exposure	Immediately after PCI
Radiation Exposure to Operators and Assistant Physicians	Immediately after PCI
Contrast Agent Volume	Immediately after PCI
Product Performance Evaluation	Immediately after PCI
Incidence of Major Adverse Cardiovascular Events (MACE)	Immediately after PCI and 1 month after PCI
Incidence of Adverse Events and Serious Adverse Events	Immediately after PCI and 1 month after PCI
Incidence of Device Deficiencies	Immediately after PCI

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 2025-2800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All IPD will not be shared for consideration of personal privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No