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The goal of this prospective, single-center, single-arm study is to explore the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI), researchers will assess the clinical success, technical success, and record the intraoperative data (PCI time, guidewire operation time, dose of contrast medium, radiation exposure doses, etc). All subjects will be followed up on the day of surgery, before discharge (or 48 hours after surgery) and 1 month after surgery to observe the safety indicators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pan-vascular interventional robotic system | Experimental | Pan-vascular interventional robotic system assisted PCI |
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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 | Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the Pan-vascular interventional robotic system, without in-hospital major adverse coronary events (MACE). | Discharge or 48 hours post intervention, whichever comes first |
| Technical Success | Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support. | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
1. General Inclusion criteria:
2. Angiographic inclusion criteria:
Exclusion Criteria:
1. General exclusion criteria:
2. Exclusion criteria for angiography:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingxing Chen, MD | Contact | 18999090210 | sunjiabao@abrobo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Shanghai | Shanghai Municipality | 200000 | China |
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| Procedure |
| Fluoroscopy Time | Total Fluoroscopy Time during procedure will be captured | Procedure |
| Radiation Exposure | Patient and Main operator radiation exposure dose recorded by portable radiation monitor during the procedure, respectively. | Procedure |
| Contrast agent dosage | The total amount of contrast agent used during the whole procedure. | Procedure |
| Kashi Prefecture Second People's Hospital | Kashgar | Xinjiang | China |
|