Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Lower Extremity Arteriosclerosis Occlusive Lumen

Peripheral Arterial Disease Clinical Trial

Official title:

A Prospective, Multicenter, Single-arm Clinical Study Was Conducted to Evaluate the Safety and Efficacy of Intravascular Interventional Surgical Instrument Control System and Related Consumables for Remote Delivery, Operation, and Withdrawal of Interventional Surgical Instruments (Guide Wire, Catheter, Stent, Balloon) During Endovascular Interventional Surgery for Lower Extremity Arteriosclerosis Occlusion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05625711
• Other study ID #: XMLY3001-02A
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: November 2022
• Source: Shanghai Operation Robot Co., Ltd.
• Contact: lu qingsheng, MD
• Phone: 021-31166666
• Email: luqs[@]newvascular.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: November 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Meet all the following criteria to be included in the group.

1. Age: 18 years old or above, regardless of gender.

2. Suffering from arteriosclerosis obliterans of lower limbs, it has the indication of endovascular treatment.

3. Volunteer to participate in the test and sign the informed consent form.

Exclusion Criteria:

• General criteria: If any of the following criteria is met, it cannot be included in the group.

1. Pregnant or lactating women, or women of childbearing age with positive pregnancy test results.

2. The target vessels were treated by arterial bypass grafting.

3. Subjects participated in other clinical trials within 3 months before the screening period.

4. Allergic history or contraindication of antiplatelet drugs, anticoagulants, anesthetics, contrast agents, scaffold materials and their coating drugs.

5. Severe infection that is difficult to control.

• 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.

1. Perforation, dissection or aneurysm of the diseased vessel or the proximal vessel of the diseased vessel.

2. The investigator believed that the vascular conditions were not suitable for the use of the test medical device.

Related Conditions & MeSH terms

• Arteriosclerosis
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• The endovascular interventional surgical instrument control system
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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai Operation Robot Co., Ltd.	Changhai Hospital, Tianjin Medical University General Hospital, Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Incidence of device defects (software, hardware)	The proportion of subjects with device defects (software, hardware) in total subjects.	intraoperative.
Primary	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
Primary	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
Secondary	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)
Secondary	Total radiation exposure per operation (surgeon, subject operating table side)	Determination method: The surgeon wears a radiation measuring device on his chest to record the total radiation exposure during surgery.; Radiation measuring devices were placed around the umbilicus to record the total radiation exposure during surgery.; 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.
Secondary	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