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| Name | Class |
|---|---|
| Changhai Hospital | OTHER |
| Tianjin Medical University General Hospital | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
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This trial was a prospective, multicenter, single-group design. To undergo endovascular treatment of lower extremity arteriosclerosis obliterans After the subjects were selected and enrolled, the surgeons used the endovascular interventional surgical instrument control system developed by Shanghai Aopeng Medical Technology Co., Ltd. and the consumables of the endovascular interventional surgical instrument control system for the interventional hand Instrumentation (guide wire, catheter, stent, balloon) for remote delivery, manipulation, and withdrawal
This study will verify the safety and effectiveness of the device in human peripheral vascular diseases, and verify 1. the degree of precision of its operation 2. the function of reducing radiation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot assisted surgery | Experimental | The robot will assist doctors to complete lower limb artery surgery, including but not limited to the transfer and withdrawal of guide wire, catheter and stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The endovascular interventional surgical instrument control system | Device | The endovascular interventional surgical instrument control system is based on the analysis of the operation behavior of doctors and their assistants in the process of manual intervention. It simulates the coordinated movement of four manipulators, completes the advance and retreat of the catheter and guide wire cavity, and realizes the different actions of wire feeding along the tube, wire feeding along the wire, wire twisting coordination, wire replacement, stent release, etc. |
| Measure | Description | Time Frame |
|---|---|---|
| Equipment technical success rate | After the endovascular treatment was completed by the surgeon using the experimental medical instrument, the proportion of subjects with successful equipment technology was achieved in the total enrolled subjects. | immediately after operation |
| Surgical technique success rate | The proportion of subjects with successful surgical technique in the total enrolled subjects was achieved after the intravascular treatment of lower extremity arteriosclerosis occlusion with experimental medical instruments. | immediately after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Rutherford grading change | The surgeon evaluated the subjects' symptoms of lower limb ischemia according to the Rutherford scale [13]. | 4 days after surgery or discharge (depending on which comes first) |
| Total radiation exposure per operation (surgeon, subject operating table side) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (equipment-related, all-cause) | The proportion of subjects with an adverse event (equipment-related, all-cause) among all subjects. | Intraoperative to postoperative 4 days or discharge day (depending on which comes first) |
| Incidence of device defects (software, hardware) |
Inclusion Criteria:
Meet all the following criteria to be included in the group.
Exclusion Criteria:
General criteria: If any of the following criteria is met, it cannot be included in the group.
Vascular criteria: According to the CTA judgment of the diseased vessels, if any of the following criteria is met, they can not be included in the group.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| lu qingsheng, MD | Contact | 021-31166666 | luqs@newvascular.cn |
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Determination method:
Simulate the maximum total unguarded radiation exposure of the primary operator with full manual operation. |
| The whole process from the beginning to the end of the operation was recorded. |
| Satisfaction rate of equipment operation (convenience, stability) | Scores of the Equipment Operation Evaluation Scale (Convenience, stability) used by surgeons who used experimental medical instruments to complete endovascular treatment of lower extremity arteriosclerosis occlusion. | Immediately after |
The proportion of subjects with device defects (software, hardware) in total subjects. |
| intraoperative. |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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