coronary calcified stenosis
Conditions
Interventions
Test group:Coronary Intravascular Lithotripsy(IVL) Catheter and Intravascular Lithotripsy Therapeutic Generator
Sponsors
Wuhan Asia Heart Hospital/Shanxi Cardiovascular Diseases Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.18 = 1 year; 3.Patients with asymptomatic evidence of myocardial ischemia, stable or asymptomatic angina pectoris, and old myocardial infarction who are suitable for interventional treatment; 4.The target lesion is the primary and in situ coronary artery; 5.The reference vessel diameter for target lesions is 2.5-4.0mm, and the length is = 70% or >= 50% (visually) accompanied by evidence of ischemia, and the doctor determines that stent implantation is necessary; 7.Clear high-density shadows can be seen both when the heart is beating and not beating (referring to the definition of moderate to severe calcification in the diagnosis and treatment of coronary artery calcification lesions in the Chinese expert consensus (2021 edition)); 8.Only one target lesion that requires shock waveguide treatment is allowed; 9.The target lesion is the only lesion that needs to be treated this time (non target lesions will be treated 30 days after surgery); 10.Target vessel TIMI blood flow level 3 before using the experimental device (pre dilation allowed); 11.Those who understand the purpose of the experiment, voluntarily participate and sign an informed consent form, and are willing to conduct clinical follow-up as required.
Exclusion criteria
Exclusion criteria: 1.New York Heart Function Classification (NYHA) III or IV; 2.Left ventricular ejection fraction (LVEF)90 ° or three or more bends>75 °), making it difficult for the test instrument to reach the target position or retrieve it; 14. Patients who have been implanted with pacemakers and cardiac rhythm devices; 15. There is an aneurysm within a 10mm range of the target lesion; 16. Patients known to be allergic to heparin, contrast agents, aspirin, clopidogrel, and anesthetics; 17. The subject is currently participating in another clinical study of a drug or device that has not yet completed its primary endpoint; 18. Pregnant or lactating women; 19. Researchers believe that other patients should be excluded;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedural success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;Angiographic success rate;Target lesion failure;Device performance evaluation;Optical coherence tomography (OCT) evaluation metrics;Major Adverse Cardiovascular Events;AE and SAE;Vital signs (blood pressure, pulse, respiration, body temperature) and physical examination;Clinical laboratory tests; | — |
Countries
China
Contacts
Public ContactSong dan/Han Xuebin
Wuhan Asia Heart Hospital/Shanxi Cardiovascular Diseases Hospital
Outcome results
None listed