Coronary heart disease
Conditions
Interventions
single-group:coronary IVL
Sponsors
Fuwai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 - 75 years old. 2) Clinically diagnosed with stable or unstable angina pectoris, asymptomatic myocardial ischemia, or old myocardial infarction. 3) The target lesion is the only lesion to be treated in this procedure. 4) Target lesion: 1. Native or in-stent restenosis lesion with a reference vessel diameter between 2.0 - 4.0 mm (by visual inspection). 2. Lesion length= 70% (by visual inspection); or 50% >= lesion diameter stenosis < 70% (by visual inspection) with evidence of myocardial ischemia. 4. Severe calcification: Clear high-density shadows can be seen on the arterial wall of the target lesion when the heart is beating and not beating under X-ray. 5. Before using the test device, the target vessel has TIMI flow grade 3. 5) Signed the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion Criteria - Non-imaging 1) Simultaneous planned use of any rotational atherectomy catheter, laser ablation catheter, special balloons (including double-wire balloons, scoring balloons, cutting balloons, or spiked balloons, etc.) for pretreatment of the target lesion. 2) Implantation of a permanent pacemaker. 3) Acute myocardial infarction within 30 days. 4) Severe cardiac insufficiency (NYHA cardiac function class III/IV or LVEF 221 µmol/L or undergoing hemodialysis. 8) Severe allergy or contraindication to antiplatelet drugs, anticoagulants, or contrast agents, etc. 9) Planned elective surgery within 1 month that requires discontinuation of antiplatelet or anticoagulant drugs. 10) Mental abnormalities or a history of mental illness resulting in inability to cooperate independently. 11) Lactating/pregnant women or women of childbearing age planning to conceive. 12) Currently participating in other interventional clinical trials. 13) Judged by the investigator as not suitable for inclusion in this trial. Exclusion Criteria - Imaging 1) The target lesion is an unprotected left main coronary artery lesion (left main coronary artery diameter stenosis >=50% by visual inspection). 2) The target lesion is located at or involves within 5 mm of the ostia of the left anterior descending artery, left circumflex artery, or right coronary artery. 3) The target lesion is a chronic total occlusion (CTO). 4) The target lesion is a bifurcation lesion with a branch vessel diameter > 2.5 mm. 5) There is an aneurysm within 10 mm proximal or distal to the target lesion. 6) The target lesion is located at the distal end of a saphenous vein graft or arterial graft bypass. 7) Before using the test device, there is a flow-limiting dissection (NHLBI type C or above) or perforation in the target vessel. 8) Angiography confirms the presence of a thrombus in the target vessel. 9) Angiography shows that the access vessel has a tortuous path, making it difficult for the guide wire to reach the target position or be retrieved
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedural Success; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device Success;Angiographic Success;Immediate Residual Stenosis of the Target Lesion after Using the Test Device;Incidence of MACE within 30 Days after the procedure;Clinically Driven Target Lesion Revascularization (CD-TLR) within 30 Days after the procedure;Adverse Events;Serious Adverse Events;Device Defects; | — |
Countries
China
Contacts
Public ContactYang weixian/ Yuan jiansong
Fuwai Hospital
Outcome results
None listed