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 | Not Yet Recruiting DMC

• 1 other identifier: 2025-2800
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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. 1.Whether the PCI-assisted procedure was clinically successful and technically successful?
2. 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Clinical Success Rate

  Immediately after PCI

• Technical Success Rate

  Immediately after PCI

Secondary Outcomes (10)

• 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

Study Arms (2)

vascular interventional robotic system group

EXPERIMENTAL

Undergoing PCI using the vascular interventional robotic group

Device: vascular interventional robotic system

human operator group

OTHER

Undergoing PCI with human operators

Device: human operator

Interventions

vascular interventional robotic system DEVICE

Patients all undergoing PCI with vascular interventional robotic system

vascular interventional robotic system group

human operator DEVICE

Patients undergoing PCI by human operators

human operator group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Xicheng District, 100037, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Bowen Li

CONTACT

01088396584; libowen@fuwai.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)