NCT05625711

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Shanghai Operation Robot Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-06-01
• Completion: 2024-11-01
• First posted: 2022-11-23
• Last updated: 2022-11-23