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

Not Applicable

Not yet recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Device: The endovascular interventional surgical instrument control system

• Registration Number: NCT05625711
• Lead Sponsor: Shanghai Operation Robot Co., Ltd.

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

Study Timeline

• Study First Submitted: 2022-10-26
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-22
• Last Update Submitted: 2022-11-22
• Study First Posted: 2022-11-23
• Last Update Posted: 2022-11-23
• Study Start: 2022-12-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robot assisted surgery	The endovascular interventional surgical instrument control system	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

Primary Outcome Measures

Name	Time	Method
Surgical technique success rate	immediately after operation	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.
Equipment technical success rate	immediately after operation	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.

Secondary Outcome Measures

Name	Time	Method
Total radiation exposure per operation (surgeon, subject operating table side)	The whole process from the beginning to the end of the operation was recorded.	Determination method: 1. The surgeon wears a radiation measuring device on his chest to record the total radiation exposure during surgery.; 2. 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.
Satisfaction rate of equipment operation (convenience, stability)	Immediately after	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.
Rutherford grading change	4 days after surgery or discharge (depending on which comes first)	The surgeon evaluated the subjects' symptoms of lower limb ischemia according to the Rutherford scale \[13\].