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

Обзор

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.

Вмешательства

• Устройство vascular interventional robotic system
  Patients all undergoing PCI with vascular interventional robotic system
• Устройство human operator
  Patients undergoing PCI by human operators

Первичные конечные точки

• Clinical Success Rate [Срок оценки: Immediately after PCI]
• Technical Success Rate [Срок оценки: Immediately after PCI]

Вторичные конечные точки (10)

• Total procedure time [Срок оценки: Immediately after PCI]
• PCI time [Срок оценки: Immediately after PCI]
• Rate of Successful Guiding Catheter Manipulation [Срок оценки: Immediately after PCI]
• Patient Radiation Exposure [Срок оценки: Immediately after PCI]
• Radiation Exposure to Operators and Assistant Physicians [Срок оценки: Immediately after PCI]
• Contrast Agent Volume [Срок оценки: Immediately after PCI]
• Product Performance Evaluation [Срок оценки: Immediately after PCI]
• Incidence of Major Adverse Cardiovascular Events (MACE) [Срок оценки: Immediately after PCI and 1 month after PCI]
• Incidence of Adverse Events and Serious Adverse Events [Срок оценки: Immediately after PCI and 1 month after PCI]
• Incidence of Device Deficiencies [Срок оценки: Immediately after PCI]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.
• Presence of visible thrombus.
• The target lesion is located in the left main coronary artery.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fuwai Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT07233317 · 2025-2800

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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