Coronary heart disease
Conditions
Interventions
Control group:Noncompliant balloon interventional therapy
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Aged between 18 and 80; 2) The subjects have clinical indications for PCI; 3) Heart disease with clinical evidence of ischemia (such as stable/unstable angina pectoris, old myocardial infarction or asymptomatic myocardial ischemia); 4) Willing to participate in the clinical trial and sign the informed consent. Selection criteria for target vessel imaging:Expected to require shock wave therapy for only one target lesion, which is primary coronary artery disease; The visual diameter of the target vessel (RVD) is between 2.5 and 4.0 mm (inclusive); Disease length <= 40 mm; Coronary angiography shows moderate to severe calcified lesions, or OCT evaluation shows deep calcifications or superficial calcifications with a calcification score of <= 4, or IVUS shows calcified lesions; Poor stent expansion: After implantation of the target lesion stent and balloon dilation, the absolute value of MSA evaluated by OCT is <= 4.5mm2 (absolute expansion) or MSA is <= 80% of the average reference area (relative expansion).
Exclusion criteria
Exclusion criteria: 1) Acute myocardial infarction occurred within 30 days before surgery; 2) Patients with intracardiac thrombus within 30 days before surgery; 3) Severe cardiac insufficiency (NYHA grade III or IV); 4) Subjects who have received or are waiting for an organ transplant; 5) Patients with contraindications of coronary artery bypass surgery; 6) Serious insufficiency of other organs (lung, liver, kidney); 7) Subjects with known allergy or contraindications to antiplatelet or anticoagulant drugs that prevent them from receiving adequate preoperative medication;8) Platelets (PLT) 700×10^9/L, as well as anticoagulant, antiplatelet therapy contraindication and obvious bleeding tendency; 9) Subjects who are known to be allergic to the components or contrast agents in the test product; 10) Patients with advanced malignant tumors, end-stage tumors, requiring chemoradiation or life expectancy of less than 1 year; 11) Serum creatinine levels in the 14 days before surgery > 2.5mg/dl (or 221 µmol/L); 12) Cerebrovascular accident (CVA) occurred within 3 months before surgery; 13) Active peptic ulcer or active gastrointestinal bleeding occurred within 3 months before surgery;14) Subjects who are known to be pregnant or breastfeeding (pregnancy test results for women of childbearing age within 14 days before surgery should be negative); 15) Subjects who are participating in clinical studies of other drugs or devices; 16) Other conditions assessed by the investigator as unsuitable for participation in the clinical trial. Exclusion criteria for target vessel imaging: Pre treatment of coronary artery calcification lesions before stent implantation using IVL;Coronary artery opening lesion (within 5mm from the opening);Fork lesion, and the branch requires stent implantation;The proximal or internal end of the target lesion is extremely angled (>=45 °);The target lesion is previous stent restenosis;The target lesion is chronic complete occlusion;The target lesion is located within the arterial bridge, venous bridge, or anastomotic site;Severe dissection (grade D to F) of the target lesion occurred before using the research instrument;The target lesion is an unprotected left main trunk lesion (diameter stenosis>50%);Protective left main artery disease (diameter stenosis>50%, left coronary artery undergoing bypass surgery), target lesion located in LAD or LCX;Spasms occur in the target blood vessel but there is no significant stenosis;Significant thrombus rich lesions;Non target lesions cannot be treated before target lesions or treatment fails;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success rate of stent malexpansion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Image success rate;Equipment success rate;Minimum stent area; | — |
Countries
China
Contacts
Public ContactJunbo Ge
Zhongshan Hospital Fudan University
Outcome results
None listed