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

NCT05625711 | Unknown

• 1 other identifier: XMLY3001-02A
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

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

Conditions

Peripheral Arterial Disease

Keywords

robot; peripheral arterial

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Rutherford grading change

  4 days after surgery or discharge (depending on which comes first)

• Total radiation exposure per operation (surgeon, subject operating table side)

  The whole process from the beginning to the end of the operation was recorded.

• Satisfaction rate of equipment operation (convenience, stability)

  Immediately after

Other Outcomes (2)

• Incidence of adverse events (equipment-related, all-cause)

  Intraoperative to postoperative 4 days or discharge day (depending on which comes first)

• Incidence of device defects (software, hardware)

  intraoperative.

Study Arms (1)

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

Device: The endovascular interventional surgical instrument control system

Interventions

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.

Robot assisted surgery

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet all the following criteria to be included in the group.
• Age: 18 years old or above, regardless of gender.
• Suffering from arteriosclerosis obliterans of lower limbs, it has the indication of endovascular treatment.
• Volunteer to participate in the test and sign the informed consent form.

You may not qualify if:

• General criteria: If any of the following criteria is met, it cannot be included in the group.
• Pregnant or lactating women, or women of childbearing age with positive pregnancy test results.
• The target vessels were treated by arterial bypass grafting.
• Subjects participated in other clinical trials within 3 months before the screening period.
• Allergic history or contraindication of antiplatelet drugs, anticoagulants, anesthetics, contrast agents, scaffold materials and their coating drugs.
• 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.
• Perforation, dissection or aneurysm of the diseased vessel or the proximal vessel of the diseased vessel.
• The investigator believed that the vascular conditions were not suitable for the use of the test medical device.

Sponsors & Collaborators

• Shanghai Operation Robot Co., Ltd.: lead
• Changhai Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

lu qingsheng, MD

CONTACT

021-31166666; luqs@newvascular.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 23, 2022
• Study Start: December 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share