Clinical trial NCT05625711: Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Lower Extremity Arteriosclerosis Occlusive Lumen
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: robot
peripheral arterial
Lead sponsor: Shanghai Operation Robot Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Changhai Hospital
name: Tianjin Medical University General Hospital
name: Xuanwu Hospital, Beijing
First posted: 2022-11-23
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Equipment technical success rate
timeFrame: immediately after operation
measure: Surgical technique success rate
timeFrame: immediately after operation
Secondary outcomes:
measure: Rutherford grading change
timeFrame: 4 days after surgery or discharge (depending on which comes first)
measure: Total radiation exposure per operation (surgeon, subject operating table side)
timeFrame: The whole process from the beginning to the end of the operation was recorded.
measure: Satisfaction rate of equipment operation (convenience, stability)
timeFrame: Immediately after
Other outcomes:
measure: Incidence of adverse events (equipment-related, all-cause)
timeFrame: Intraoperative to postoperative 4 days or discharge day (depending on which comes first)
measure: Incidence of device defects (software, hardware)
timeFrame: intraoperative.
Locations:
Study officials:
References: