Chronic total occlusion
Conditions
Interventions
Test preparation: Bivalirudin
Reference preparation:Heparin sodium injection
Sponsors
The Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Subjects are fully aware of the purpose, nature, methods, and possible adverse effects of the test, volunteered as a subject, and signed an informed consent form prior to the start of the study procedure; 2) Aged 18-75 years; 3) Male weight >= 40.0 kg, female weight >= 35.0 kg; 4) Comply with CTO lesion diagnostic criteria, coronary angiography or CT angiography showed complete occlusion of the vessel, occluded vessel diameter >2.5 mm, coronary angiography showed blood flow grading to TIMI 0; collateral circulation; combined with clinical data, corresponding Coronary artery occlusion time > 3 months; 5) There is a CTO lesion in a single coronary artery, and the remaining coronary arteries do not require interventional therapy or have completed revascularization; 6) There is clear evidence of ischemia, the effect of conservative treatment with drugs is not good, affecting the quality of life of patients; 7) Subjects are able to communicate well with the investigator and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1) Contrast of ruthenium, heparin or any drug component with a history of allergies; 2) Patients who have received other clinical trials in the past month; 3) >= 2 coronary occlusions; 4) Patients with J-CTO score >= 3 points (occlusion morphology, degree of calcification, curvature > 45 degree, occlusion length >= 20 mm, re-injury); 5) The distal end of the occluded blood vessel is small and there is no evidence of clear ischemia; 6) Acute myocardial infarction, severe valvular heart disease, dilated cardiomyopathy and hypertrophic cardiomyopathy ; 7) New York Heart Association (NYHA) cardiac function grade III and above or cardiogenic shock; 8) Suspicious aortic dissection patients; 9) Patients who have undergone CABG surgery; 10) Patients with advanced cancer; 11) Patients with severe liver and kidney dysfunction; 12) Platelet count <100×10^9 /L or hemoglobin <100 g/L; 13) The need to delay or interrupt dual antiplatelet therapy for any reason; 14) Severe organic disease; 15) lactating or pregnant women; 16) A recent history of active bleeding, including gastrointestinal bleeding in the past 3 months, cerebral hemorrhage within 6 months, and a history of cerebral infarction within 3 months is not suitable for PCI; 17) Other investigators determine subjects who are not suitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Electrocardiogram;Echocardiography;Blood biochemical tests; | — |
Countries
China
Contacts
Public ContactXue Bai
The Affiliated Hospital of Southwest Medical University
Outcome results
None listed