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The purpose of this prospective, randomized, open, parallel controlled, multicenter trial is to investigate the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI). Investigators will evaluate clinical success, technical success, and record intraoperative data (PCI time, total operating time, contrast agent dose, radiation exposure dose, etc.). All subjects were followed up on the day of surgery, before discharge and 1 month after surgery to observe the safety indicators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pan-vascular interventional robotic system group | Experimental | Pan-vascular interventional robotic system assisted PCI |
|
| Artificial control group | Experimental | Traditional artificial percutaneous coronary intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pan-vascular interventional robotic system | Device | Pan-vascular interventional robotic system assited PCI for delivery and manipulation of guidewires, catheters, and quick exchange balloon dilatation catheters/stents. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success | Immediate postoperative angiography showed residual stenosis < 30% and TIMI blood flow fraction Level 3. | Immediate postoperative angiography |
| Clinical Success | No MACE occurred in hospital. | Discharge or 48 hours post intervention, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate |
| Procedure |
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Inclusion Criteria:
1. General Inclusion criteria:
2. Angiographic inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junbo Ge | Contact | 13767518896 | sunjiabao@abrobo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital,Capital Medical University | Beijing | Beijing Municipality | 100000 | China |
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| Traditional artificial percutaneous coronary intervention | Procedure | Doctors perform traditional percutaneous coronary intervention |
|
| Radiation Exposure | Patient and Main operator radiation exposure dose recorded by portable radiation | Procedure |
| Fluoroscopy Time | Total Fluoroscopy Time during procedure will be captured. | Procedure |
| Contrast agent dosage | The total amount of contrast agent used during the whole procedure. | Procedure |
| Procedure Time | Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. | Procedure |
| PCI time | Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. | Procedure |
| the Pan-vascular Interventional Robotic Systemt performance evaluation | The performance of the product was subjectively evaluated by the surgeon. | After the operation |
| The First Affiliated Hospital,Sun Yat-sen University | Guanzhou | Guandong | 510080 | China |
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| Linfen Central Hospital | Shanxi | Linfen | 041000 | China |
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| Shanghai Zhongshan Hospital | Shanghai | Shanghai Municipality | 200000 | China |
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| The Affiliated Hospital of Hangzhou Normal University | Hangzhou | Zhejiang | 310000 | China |
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