Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Percutaneous Coronary Intervention

Launched by SHANGHAI OPERATION ROBOT CO., LTD. · Dec 7, 2022

Keywords

ClinConnect Summary

Interventional therapy plays an important role in the treatment of coronary heart disease. At present, the main treatment methods still rely on human hands, and there are some defects, including but not limited to hand shaking and visual error. The use of robots may partly circumvent the above shortcomings.

This study is to evaluate the safety and effectiveness of ALLVAS®robot for coronary artery interventional surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients who voluntarily participate in and sign the informed consent form, and can cooperate to complete the whole trial process;
• • 2. aged over 18 and under 75;
• • 3. After coronary CT angiography (CTA) or coronary angiography (DSA), the investigator judged that the patients who needed interventional blood supply reconstruction (target vessel diameter ≥ 2.5mm and lesion stenosis ≥ 70%).
• Exclusion Criteria:
• • 1. Acute myocardial infarction occurred within 7 days;
• • 2. The target vessel has received coronary intervention within 30 days;
• • 3. Restenosis in stent of target vessel;
• • 4. Patients with bifurcation lesions whose target vessel branches need to be protected but cannot protect the collateral branches;
• • 5. Hemodynamic instability (including low blood pressure or use of vasopressors to maintain blood pressure;)
• • 6. Three vessel lesions;
• • 7. The target vessel was diagnosed as coronary chronic occlusive disease (CTO) or left main artery stenosis or severe calcification requiring pretreatment;
• • 8. Perforation, dissection or aneurysm of the proximal vessel of the target vessel;
• • 9. Echocardiography showed that left ventricular ejection fraction (LVEF) was less than 50%;
• • 10. Stroke or transient ischemic attack (TIA) occurred within 30 days;
• • 11. Peptic ulcer or gastrointestinal bleeding within 90 days;
• • 12. Estimated glomerular filtration rate eGFR (ckd epi)\<30 ml/min/1.73 m2;
• • 13. Platelet count\<50 × 109/L or \> 700 × 109/L； White blood cell count \< 3 × 109/L;
• • 14. Women who are in pregnancy or lactation or have a pregnancy preparation plan during the trial period;
• • 15. People with allergy history or contraindication to antiplatelet drugs, anticoagulants, anesthetics, contrast agents, stent materials and their coating drugs;
• • 16. Severe infections difficult to control;
• • 17. Those who have mental diseases or mental disorders and cannot be described normally;
• • 18. Emergency operation is required for any reason;
• • 19. Those who have participated in clinical trials of other drugs or medical devices within 3 months before screening;
• • 20. The investigator believes that there are other circumstances that are not suitable for this clinical trial.