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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vascular interventional robotic system group | Experimental | Undergoing PCI using the vascular interventional robotic group |
|
| human operator group | Other | Undergoing PCI with human operators |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vascular interventional robotic system | Device | Patients all undergoing PCI with vascular interventional robotic system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success Rate | Immediately after PCI | |
| Technical Success Rate | Immediately after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Total procedure time | Immediately after PCI | |
| PCI time | Immediately after PCI | |
| Rate of Successful Guiding Catheter Manipulation |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bowen Li | Contact | 01088396584 | libowen@fuwai.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing | Xicheng District | 100037 | China |
All IPD will not be shared for consideration of personal privacy
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| human operator | Device | Patients undergoing PCI by human operators |
|
| 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 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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