Severe calcification lesions of coronary artery blood vessels
Conditions
Interventions
Experimental group:Coronary artery shock wave gravel system
Sponsors
Tangdu Hospital of Air Force Millitary Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years, male or non-pregnant female; 2. Patients with asymptomatic myocardial ischemia, stability or instability with angina, or obsolete heart infarction; 3. Target disease becomes primary, in situ coronary artery lesions; 4. Target lesions reference blood vessel diameter 2.5-4.0 mm, length = 70% or >= 50% (visual) and is accompanied by evidence of ischemicity; 6. The lesion allows 0.014'' guide wire to pass through; 7. Clear, high-density shadows can be seen when the heart beats and does not beat; 8. Target disease becomes the only lesions that require treatment at this time; 9. Target blood vessel TIMI blood flow level 3 (pre-dilation allowed) before the use of test instruments; 10. Suitable for patients receiving PTCA, PCI treatment; 11. Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign the written informed consent, and can receive follow-up patients.
Exclusion criteria
Exclusion criteria: 1. A mezzanine exists in the target blood vessel after preoperative angiography or wire guide passes through; 2. The stent has been implanted within 10 mm of the near or far end of the target lesion; 3. The target lesions are located within 5 mm of the opening of the right crown before or after the drop, swing, and right crown; 4. Left backbone lesions or bridge vascular lesions; 5. The contrast shows that the blood vessel path is twisting, and the test instrument is difficult to reach the target position or to recover; 6. At the same time, it is planned to cut the balloon, the eternity balloon, the mammoth balloon, the plaque spin grinding, laser wear corrosion treatment patient; 7. Have a history of active peptic ulcers or gastrointestinal bleeding within 6 months of joining the group; 8. Patients with a definitive diagnosis of malignant tumors or 2.5 mg/dL (221 umoI/L) or chronic renal failure requiring long-term dialysis; 12. New York Heart Association Rating (NYHA) III or Class IV; 13. Patients known to be allergic to heparin, contrast agents, aspirin and clopidogrel, anesthetics; 14. Participants in clinical trials of other drugs or devices are not completed; 15. The researchers judged that compliance was poor and that the subjects who had not completed the study were not able to complete the study as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of surgery;Angiographic success rate (residual stenosis <= 30%); | — |
Secondary
| Measure | Time frame |
|---|---|
| No MACE(major adverse cardiovascular events) event rate;The incidence of target lesion failure;Device utilization rate;Incidence of severe angiographic complications;Incidence of MACE events;Incidence of serious adverse events;Incidence of device defects;Minimum stent area immediately after operation;Minimal lumen diameter (MLD) immediately after operation;The diameter of lumen was obtained immediately after operation;Lumen area immediately after operation;Immediate postoperative lumen acquisition rate;Support expansion rate;Incomplete adherence rate of support beam; | — |
Countries
China
Contacts
Public ContactLi Yan
Tangdu Hospital of Air Force Millitary Medical University
Outcome results
None listed