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

NCT ID: NCT05625711

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-11-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robot assisted surgery

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

Group Type: EXPERIMENTAL

The endovascular interventional surgical instrument control system

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Shanghai Operation Robot Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

lu qingsheng, MD

Role: CONTACT

luqs@newvascular.cn

021-31166666

Other Identifiers

XMLY3001-02A

Identifier Type: -

Identifier Source: org_study_id