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

Shanghai Operation Robot

Status: Not yet enrolling

Conditions: Peripheral Arterial Disease

Treatments: Device: The endovascular interventional surgical instrument control system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05625711

XMLY3001-02A

Details and patient eligibility

About

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

Full 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

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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260 participants in 1 patient group

Robot assisted surgery

Experimental group

Description:

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

Treatment:

Device: The endovascular interventional surgical instrument control system