Calcified coronary artery lesions
Conditions
Interventions
control group:Shockwave therapy system
Sponsors
Beijing Anzhen Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: 1. Age 18-85 years old, male or female; 2. Patients with evidence of asymptomatic ischemia, stable or unstable angina, or old myocardial infarction; 3. Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and are willing to undergo imaging, OCT examination and clinical follow-up. Imaging Inclusion Criteria: 1. The target lesion is a primary, in situ coronary artery lesion; 2. The length of the target lesion <= 40mm, and the diameter of the reference blood vessel of the target lesion is 2.0-4.0mm (visual inspection); 3. The degree of stenosis of the diameter of the target lesion is visually =70%, or < 70% and =50% with evidence of ischemia; 4. Clear and high-density shadows can be seen when the heart is beating and not beating; 5. Grade 3 TIMI blood flow of target blood vessels before the use of test devices or control devices (pre-dilation is allowed); 6. The target lesion is the only calcified lesion treated by this shock wave; 7. Patients who are suitable for metal stenting treatment.
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1. ST-elevation myocardial infarction occurred within 3 days before surgery; 2. Simultaneous use of rotational atherectomy or special balloons (chocolate balloons, scoring balloons, cutting balloons, double guidewire balloons, spinous balloons, etc.) to treat lesions; 3. New York Cardiac Functional Classification (NYHA) Class III or IV; 4. The target lesion is expected to be implanted with a fully degradable stent, drug balloon dilation, and PTCA therapy; 5. Uncontrolled severe hypertension (persistent: systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg); 6. Severe liver and kidney impairment, transaminases exceeding the upper limit of normal value more than 3 times, serum creatinine > 2.5 mg/dL (221 µmoI/L) or chronic renal failure requiring long-term dialysis; 7. Preoperative hemoglobin <100g/L; 8. Platelet count< 60×109/L; 9. Stroke within 6 months prior to enrollment, excluding transient ischemic attack (TIA) and luminal infarction; 10. History of active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to enrollment; 11. Patients with known allergies to heparin, contrast agents, aspirin, clopidogrel, and anesthetics; 12. Patients with a life expectancy of less than 12 months due to serious medical diseases; 13. Those who participated in clinical trials of other drugs or devices and did not meet the primary endpoint; 14. The patient is a pregnant or breastfeeding woman; 15. The investigator judged that the patient had poor compliance and was unable to complete the study in accordance with the protocol requirements. Contrast Exclusion Criteria: 1. The target lesion is an open location (LAD, LCX, or RCA, within 5 mm of the opening) or an unprotected left main lesion; 2. The proximal or distal end of the target lesion is 10mm or more inducted into the stent; 3. There are branch blood vessels with a diameter of more than 2.5mm that cannot be protected by the target lesion; 4. The target lesion is located distal to the saphenous vein or LIMA (left internal mammary artery)/RIMA (right internal mammary artery) bypass graft; 5. Presence of aneurysm within 10mm of the target lesion; 6. Imaging confirmed that the target lesion had type D-F arterial dissection according to NHLBI classification criteria before treatment with the experimental device or control device; 7. There is definite thrombosis in the target lesion; 8. Patients who are judged by the investigator to be unsuitable for vasodilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of angiography;Incidence of MACE events within 7 days postoperatively or before discharge, 1 month, 6 months postoperatively;Incidence of target lesion failure (TLF) at 1 month and 6 months postoperatively;Device success rate;Complication rate of severe angiography;Incidence of serious adverse events, incidence of adverse events;Incidence of device defects; | — |
Countries
China
Contacts
Public ContactZhou Yujie
Beijing Anzhen Hospital Affiliated to Capital Medical University
Outcome results
None listed