In-stent restenosis due to poor coronary stent inflation
Conditions
Interventions
FIM group:The use of intravascular shock wave therapy equipment produced by Shanghai Lanfan Boyuan Medical Technology Co., Ltd. and disposable coronary intravas
Confirmatory clinical trials group:The use of intravascular shock wave therapy equipment produced by Shanghai Lanfan Boyuan Medical Technology Co., Ltd. and disposable coronary intravas
Confirmatory control group:Use of a non-compliant balloon dilatation catheter
Sponsors
Beijing Luhe Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old, male or non-pregnant female; 2. Cardiac disease with clinical evidence of ischemia, such as chronic coronary syndrome (CCS) or acute coronary syndrome (ACS); 3. Subjects can understand the purpose of the trial, voluntarily participate and sign the informed consent form; 4. The target lesion is severe calcification (one of the following is sufficient) (1) OCT evaluation calcification score is 4 points; (2) IVUS was evaluated as grade IV. (calcification range>= 271°) according to the extent of calcified lesion involvement in the vascular lumen; 5. The target lesion is stent inflatable (one of the following is sufficient) (1) The minimum stent area (MSA) assessed by OCT = 70% or >= 50% (visual inspection) with evidence of ischemia.
Exclusion criteria
Exclusion criteria: 1. Patients with any myocardial infarction within 1 week, or patients who have had myocardial infarction for more than one week but have not returned to normal myocardial enzymes CK or CK-MB; 2. Patients with New York Cardiac Function Class (NYHA) class III or IV or severe valvular heart disease; 3. Female patients who are planning or are pregnant (or breastfeeding); 4. Severe liver and kidney impairment, transaminase exceeding the upper limit of normal value by more than 3 times, serum creatinine > 2.5 mg/dL (221 µmoI/L) or chronic renal failure requiring long-term dialysis; 5. Severe hypertension that cannot be controlled by treatment (systolic blood pressure sustained > 180 mmHg or diastolic blood pressure sustained >110 mmHg); 6. Coagulation disorders, platelet count < 100×10^9/ L; 7. Patients with cardiogenic shock; 8. Patients who need to receive cytostatics or radiotherapy for concomitant diseases; 9. Patients with known allergies to heparin, contrast agents, aspirin and clopidogrel, and anesthetics; 10. Patients with bleeding constitution, or a history of cerebral hemorrhage, active peptic ulcer, or gastrointestinal bleeding within the past 6 months, will be restricted or prohibited from using anticoagulant therapy or anticoagulant drugs; 11. Patients with a life expectancy of no more than 6 months or underlying factors that make clinical follow-up difficult; 12. Patients who are participating in any other clinical trials; 13. Patients who are not suitable for inclusion due to other reasons; 14. The target lesion has 2 layers or more stents; 15. The target lesion is an open location (LAD, LCX, or RCA, within 3 mm of the opening) or an unprotected left main lesion; 16. The target lesion has branch vessels with a diameter of more than 2.5mm that cannot be protected; 17. Patients who have undergone CABG before; 18. Aneurysm within 10mm of the target lesion; 19. Clear thrombosis in the target lesion; 20. Patients whose target lesions are judged by the investigator to be unsuitable for vasodilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Severe angiographic complication rate (intraoperative);Incidence of MACE (before discharge, 1 month and 6 months after surgery);Incidence of device defects;Technical success rate;Incidence of serious adverse events, incidence of adverse events (before discharge, 1 month and 6 months after surgery);Device success rate;Incidence of target lesion failure (TLF) (1 month, 6 months postoperatively); | — |
Countries
China
Contacts
Public ContactZhai Guangyao
Beijing Luhe Hospital Affiliated to Capital Medical University
Outcome results
None listed