Coronary artery disease
Conditions
Interventions
Control group:Extracorporeal membrane oxygenation system assists high-risk percutaneous coronary vascular intervention
Experimental group:Interventional left ventricular assist system assisted high-risk percutaneous coronary vascular intervention
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. 18-90 years old; 2. The subject is diagnosed with acute or chronic coronary syndrome and requires coronary artery revascularization, and after the investigator's assessment, it is believed that Coronary Artery Bypass Grafting (CABG) has a high risk or the patient (including family members) refuses to accept CABG, and can benefit from percutaneous coronary intervention (Percutaneous Coronary Intervention, PCI); 3. Subject's cardiac ultrasound left ventricular ejection fraction =50%; ii. The vessel to be treated for intervention is the last unobstructed vessel ,anterior descending artery, circumflex artery or right coronary artery; iii. Venous bridge vascular lesions; iv. Severe calcification, tortuous long lesions ,requiring atherectomy; v. Multivessel disease ,two or more vessels combined with chronic total occlusion ;vi. Three vessel lesions; *Definition of three vessel lesions: At least one significant stenosis of each of the three major epicardial coronary arteries left anterior descending and/or its branches, left circumflex branch and/or its branches, right coronary artery and/or its branches, and significant stenosis is defined as luminal stenosis >=70%. For the left dominant coronary artery, both the left anterior descending artery and the proximal left circumflex branch are present>= and 50% stenosis is also considered as a three-branch lesion. 5. Subjects or their legal guardians voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have had cardiogenic shock within 7 days before enrollment: systolic blood pressure = 90 mmHg, and patients with end-organ hypoperfusion (wet and cold limbs, or urine output = 2.0 or fibrinogen =4mg/dl /353.6umol/L) within 7 days before enrollment, or dialysis treatment; 17. Hepatic insufficiency: Aspartate Aminotransferase , alanine aminotransferase and bilirubin levels higher than 3 times the upper limit of normal within 7 days before enrollment; 18. Presence or suspicion of infective endocarditis or systemic active infection; 19. Subject is pregnant or lactating or expects to have a pregnancy plan during the study; 20. Participating in another clinical study; 21. Other conditions that the investigator believes are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major adverse events at 30 days after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in left ventricular ejection fraction before discharge, 30 days and 90 days after surgery compared with baseline;Incidence of adverse events;Postoperative hospital stay;Incidence of device defects;Incidence of MACCE at 90 days postoperatively;Change of creatinine clearance rate from baseline within 24 hours after surgery;Technical success rate;Incidence of device-related serious adverse events;Mean mechanical cycle assist time;Incidence of major adverse cardiovascular and cerebrovascular events at 30 days after surgery;Hemodynamic disorders occurred within 30 days after device implantation;Postoperative intensive care unit time;Improvement of cardiac function at 30 days and 90 days after surgery;Blood transfusion rate within 30 days after surgery;Average transfusion units within 30 days postoperatively;Incidence of MAE at 90 days postoperatively;Incidence of device-related adverse events;Incidence of serious adverse events; | — |
Countries
China
Contacts
Public ContactJun Jiang
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed