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The goal of this study is to evaluate the safety and effectiveness of endovascular interventional surgery instrument control system (ALLVAS®robot)and supporting consumables for coronary artery interventional surgery.
Participants will will complete coronary intervention surgery with the assistance of robot system(ALLVAS®robot), and evaluate the effect of the use effect of robots and clinical treatment after surgery
Interventional therapy plays an important role in the treatment of coronary heart disease. At present, the main treatment methods still rely on human hands, and there are some defects, including but not limited to hand shaking and visual error. The use of robots may partly circumvent the above shortcomings.
This study is to evaluate the safety and effectiveness of ALLVAS®robot for coronary artery interventional surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot assisted surgery group | Experimental | robotic-assisted PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLVAS® robotic-assisted PCI | Device | ALLVAS® robotic-assisted PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Device Technical Success | Defined as after the operator completed intracoronary therapy of coronary artery with robot assistance, the ratio of successful subjects with instrument technology among all enrolled subjects was reached. | 1 day |
| Percentage of Participants With Clinical Procedural Success | Defined as after the operator completed intracoronary coronary artery therapy with robot assistance, the ratio of clinically successful subjects among all enrolled subjects was reached. | 3 days or hospital discharge, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table | Defined as the difference between the radiation exposure measured at the procedure table (the conventional site of the primary operator) and the radiation exposure measured at the primary operator's position during the procedure. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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prospective, multi center, single group target value design is adopted; 218 subjects who met the inclusion criteria and did not meet the exclusion criteria were planned to be included in the study, and the trial medical devices were used to assist surgery and complete follow-up, so as to evaluate the safety and effectiveness of the trial medical devices.
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| Evaluation of operational performance of experimental medical devices |
Multiple evaluation forms, including those for stability, operation convenience,interface friendliness, image clarity, need to be completed postoperatively by operator. These include one or more levels such as excellent, good, general, poor, etc. Stability refers to whether the operator has any abnormal situation during the use of the device; Operation convenience refers to whether the operator is smooth in the process of using the instrument. Interface friendliness and image clarity refer to whether the operator has any doubt or confusion about the interface image feedback during the use of the instrument and the clarity of the interface image during operation. |
| 1 day |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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