Clinical diagnoses include stable angina pectoris, unstable angina pectoris, asymptomatic myocardial ischemia, or old myocardial infarction.
Conditions
Interventions
Experimental group.:A single-use coronary waveguide combined with an intravascular wave therapy device for pre-treatment of coronary artery calcification lesions.
Sponsors
Beijing Jishuitan Hospital, Affiliated to Capital Medical University.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–80 years (inclusive). 2. Has a clear indication for percutaneous coronary intervention (PCI). 3. Clinical diagnosis of stable angina pectoris, unstable angina pectoris, silent myocardial ischemia, or old myocardial infarction. 4. The subject is able to fully understand and voluntarily sign the informed consent form, and agrees to complete all follow-up visits in accordance with the trial protocol. 5. The target lesion is a de novo native coronary lesion. 6. There is only one target lesion requiring treatment with the investigational device. 7. No more than two non-target lesions require concurrent interventional treatment, and non-target lesions must be successfully treated prior to the target lesion. 8. The target lesion is the only lesion requiring treatment in the left anterior descending artery, left circumflex artery, right coronary artery, or their major branches. 9. The target lesion has a stenosis severity of >=70%, or >=50% accompanied by at least one of the following evidence of myocardial ischemia: 1) Positive exercise stress test;2) Fractional flow reserve (FFR) =270°. 11. The reference vessel diameter of the target lesion is between 2.0 mm and 4.0 mm (inclusive). 12. The target lesion length is <=40 mm.
Exclusion criteria
Exclusion criteria: 1. Left ventricular dysfunction, or New York Heart Association (NYHA) functional class III/IV;or presence of other severe anatomical abnormalities that make the subject unsuitable for coronary interventional treatment. 2. Severe tortuosity of the target vessel. 3. Previously implanted stent located 180 mmHg or diastolic blood pressure >120 mmHg. 12. Presence of coagulation dysfunction, including but not limited to: platelet count 1.7. 13. Severe liver or renal function abnormalities: transaminase levels >3 times the upper limit of normal;serum creatinine >2.5 mg/dL, or requiring long-term dialysis therapy. 14. Stroke occurring within the past 30 days. 15. Presence of active peptic ulcer, upper gastrointestinal bleeding, or other conditions that make the subject unsuitable for PCI and antithrombotic therapy. 16. Planned to undergo other cardiovascular interventional procedures within 30 days after this PCI procedure. 17. Previous heart transplantation, or presence of an implanted ICD, pacemaker, or other special devices. 18. Known allergy or contraindication to materials contained in the investigational device or to medications required for this study (e.g., antiplatelet agents, anticoagulants, contrast media, etc.). 19. Currently participating in another clinical trial. 20. Life expectancy <1 year as assessed by the investigator. 21. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period. 22. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of thrombosis within the stent.;Immediate post-operative residual narrowing rate of the target lesion.;Incidence of major adverse cardiovascular events (MACE).;Success rate of vascular angiography.;Success rate of the procedure.; | — |
Countries
China
Contacts
Public ContactLiu Wei
Beijing Jishuitan Hospital, Affiliated to Capital Medical University.
Outcome results
None listed