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NCT05642286
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Percutaneous Coronary Intervention
Conditions: Percutaneous Coronary Intervention, Coronary Heart Disease, Robotic Surgical Procedures
Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 218
Sponsor: Shanghai Operation Robot Co., Ltd.
Summary
The goal of this study is to evaluate the safety and effectiveness of endovascular interventional surgery instrument control system (ALLVAS®robot)and supporting consumables for coronary artery interventional surgery.Participants will will complete coronary intervention surgery with the assistance of robot system(ALLVAS®robot), and evaluate the effect of the use effect of robots and clinical treatment after surgery
Eligibility Criteria
Inclusion Criteria:Patients who voluntarily participate in and sign the informed consent form, and can cooperate to complete the whole trial process;aged over 18 and under 75;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:Acute myocardial infarction occurred within 7 days;The target vessel has received coronary intervention within 30 days;Restenosis in stent of target vessel;Patients with bifurcation lesions whose target vessel branches need to be protected but cannot protect the collateral branches;Hemodynamic instability (including low blood pressure or use of vasopressors to maintain blood pressure;)Three vessel lesions;The target vessel was diagnosed as coronary chronic occlusive disease (CTO) or left main artery stenosis or severe calcification requiring pretreatment;Perforation, dissection or aneurysm of the proximal vessel of the target vessel;Echocardiography showed that left ventricular ejection fraction (LVEF) was less than 50%;Stroke or transient ischemic attack (TIA) occurred within 30 days;Peptic ulcer or gastrointestinal bleeding within 90 days;Estimated glomerular filtration rate eGFR (ckd epi)<30 ml/min/1.73
m2;Platelet count<50 × 109/L or > 700 × 109/L; White blood cell count < 3 × 109/L;Women who are in pregnancy or lactation or have a pregnancy preparation plan during the trial period;People with allergy history or contraindication to antiplatelet drugs, anticoagulants, anesthetics, contrast agents, stent materials and their coating drugs;Severe infections difficult to control;Those who have mental diseases or mental disorders and cannot be described normally;Emergency operation is required for any reason;Those who have participated in clinical trials of other drugs or medical devices within 3 months before screening;The investigator believes that there are other circumstances that are not suitable for this clinical trial.
Source: ClinicalTrials.gov (NCT05642286). StuddyBuddy aggregates publicly available trial information.