Moderate to severe calcified stenosis of the coronary artery
Conditions
Interventions
Experimental group:Coronary Shock Wave Balloon Intervention
Sponsors
Shanxi Cardiovascular Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for research participants (must simultaneously meet): General selection criteria: 1. Age 18=1 year; 3. Patients with primary coronary artery disease (including stable or unstable angina and asymptomatic myocardial ischemia) suitable for PCI; 4. Those who are able to understand the experimental content, willing to follow up according to the protocol, and voluntarily sign the informed consent form. Image inclusion criteria: 5. The reference vessel diameter for the target lesion is between 2.5mm and 4.0mm; 6. The length of the target lesion is between 5mm and 40mm (including upper and lower limits); 7. Patients with visual stenosis>=70% or>=50% of the target lesion but accompanied by clinical evidence of ischemia, who are judged by the researcher to require stent implantation; 8. For patients with moderate to severe calcification in the target lesion, calcification is defined as: a, Angiography: Prior to injection of contrast agent, calcification can be detected at least one location on both sides of the arterial wall under fluoroscopy, whether the heart is beating or not; perhaps b, Through IVUS (intravascular ultrasound), calcification of>=180 ° is present on at least one cross-section; 9. There is only one target lesion for this surgery (non target lesions will be treated 30 days after the surgery); Before using the experimental equipment, the TIMI blood flow level in the target vessel is 3 (pre dilation evaluation is allowed); 11.0.014 inch guide wire can pass through the target lesion.
Exclusion criteria
Exclusion criteria: Exclusion criteria for study participants (meeting any of the following criteria is considered exclusion): General exclusion criteria: 1. Those with a New York Heart Function Classification (NYHA) of III or IV; 2. Patients with left ventricular ejection fraction (LVEF)180mmHg or diastolic blood pressure>120mmHg); 7. Patients with active peptic ulcers or upper gastrointestinal bleeding within 6 months before surgery; 8. Refusal or unsuitability for emergency coronary artery bypass grafting (CABG) surgery; 9. Patients who plan to use intracavitary plaque rotational atherectomy or special balloons (chocolate balloon, scoring balloon, spinous process balloon, cutting balloon) for simultaneous treatment of target lesions; 10. Patients who have been implanted with pacemakers; 11. Known allergies to heparin, contrast agents, aspirin, clopidogrel, and anesthetics; 12. Currently participating in another drug or device clinical study that has not yet completed the primary endpoint; 13. Pregnant or lactating women; 14. Patients who have experienced acute myocardial infarction within 30 days prior to surgery; 15. Patients with troponin levels greater than 5 times the upper limit of normal within 7 days before surgery; 16. Other situations that clinical trial researchers consider inappropriate to participate in this trial. Image exclusion criteria: 17. Patients with aneurysms within a 10mm range of the target lesion; 18. Patients who have had stents implanted within a range of 10mm proximal or distal to the target lesion, and have clear or potential thrombosis in the target vessel; 19. If the target lesion is located in or involves the anterior descending branch, circumflex branch, or right coronal opening within 5mm (including 5mm); 20. Unprotected left main trunk lesions (visually narrowed by more than 50%); 21. Patients with chronic occlusive disease (CTO); 22. Angiography shows tortuous vascular pathways (defined as the presence of two or more bends>90 ° or three or more bends>75 °), making it difficult for the test instrument to reach the target position.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Equipment success rate;Angiography success rate;Surgical success rate two;Angiography success rate two;Residual stenosis rate of target lesion after pre-treatment of experimental equipment;Residual stenosis rate of target lesion immediately after surgery;Incidence of target vessel revascularization (TVR);Incidence of stent thrombosis;Instrument performance evaluation; | — |
Countries
China
Contacts
Public ContactWang Jingping
Shanxi Cardiovascular Disease Hospital
Outcome results
None listed