Moderate to severe calcified coronary artery stenosis
Conditions
Interventions
treatment group:Coronary lithotripsy catheter system was used for lumen preconditioning and drug-eluting stent implantation.
Sponsors
Nanjing First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. General selection criteria: (1) Age >= 18 years old; (2) Subjects have primary coronary artery disease suitable for PCI (including stable or unstable angina and asymptomatic myocardial ischemia); (3) Markers of myocardial injury: 1) For patients with unstable ischemic heart disease, biomarkers (CK-MB) must be within the normal range within 12 hours before surgery; 2) For patients with stable ischemic heart disease, biomarkers can be detected before or during surgery, (CK-MB) must be within the normal range within 12 hours before surgery or during surgery; (4) The patient is able to understand the content of the trial, voluntarily signs an informed consent form, is willing to abide by the trial protocol, and has the ability to return for regular check-ups; 2. Video selection criteria: (1) The target lesion has not been implanted with a stent within 1 year, and there is no implanted drug-eluting stent within 5mm of the target lesion; (2) The target vessel is a single new stenosis of the left main lesion, or the anterior descending artery, right coronary artery, or circumflex artery (or its branches), and has the following characteristics: 1) Visual stenosis degree >= 70% and = 50% but = 180° on at least one section; (4) The target vessel reference diameter is between 2.5 mm and 4.0 mm; (5) The length of the target lesion is >= 5 mm, but <= 40 mm; (6) The target vessel must have TIMI grade 3 before registration (it can be evaluated after pre-dilation); (7) The 0.014-inch guide wire can pass through the lesion.
Exclusion criteria
Exclusion criteria: 1. General exclusion criteria: (1) Basic condition (cardiac function): 1) Left ventricular ejection fraction (LVEF) = 50% in the same target vessel; 2) The target vessel is too tortuous, defined as the presence of two or more bends > 90° or three or more bends > 75°; 3) There is definite or possible thrombus in the target vessel; 4) There is evidence of aneurysm in the target vessel, within 10 mm from the target lesion; 5) The target lesion is located in a native blood vessel that can only be reached by saphenous vein or arterial graft bypass; 6) There is a flow-limiting dissection of NHLBI grade >= D in the target vessel before registration; 7) Chronic occlusive disease (CTO): there is CTO in other main vessels (anterior descending artery, circumflex artery, right coronary artery) other than the target vessel or there is CTO in any position of the target vessel; 8) Target lesions need to be pretreated with special balloons such as rotational atherectomy and spinous process balloons; (3) Laboratory examination: 1) Uncontrolled severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 120 mmHg); 2) Acute myocardial infarction (MI) in the past 1 month, and/or signs of active myocardial ischemia at enrollment, including elevated troponin-I or T (with elevated CK), absent Symptoms such as hemorrhagic electrocardiogram changes or chest pain; 3) Severe liver and kidney damage, transaminase more than 3 times the upper limit of normal value, creatinine > 2.5 mg/dL (221 umoI/L) or chronic renal failure requiring long-term dialysis; Note: for confirmed or suspected acute myocardial infarction Participants (judged by the main investigator and the secondary investigator) must evaluate their myocardial injury marker test results before enrollment; (4) Medical history and others: 1) History of stroke or transient ischemic attack (TIA) within 30 days; 2) Patients with active peptic ulcer or upper gastrointestinal bleeding within 30 days; 3) Have undergone PCI surgery within 14 days; 4) Patients who plan to undergo cardiovascular intervention within 30 days after the operation; 5) The patient refuses or is not suitable for emergency coronary artery bypass grafting (CABG) surgery; 6) A drug-eluting stent has been implanted in the target vessel in the past year; 7) Patients with known allergies or contraindications to the raw materials or drugs of the test products (such as antiplatelet drugs, anticoagulant drugs, contrast agents); 8) Participate in other clinical trials at the same time; 9) The expected survival of the patient is no more than 1 year; 10) Women who have family planning during pregnancy, lactation or clinical trials; 11) Factors that other researchers think cannot be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial infarction rate;Success rate of operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Angiographic success rate;Operation success rate 2;Residual stenosis rate of target lesions after preconditioning with experimental medical instruments;TIMI blood flow grading of target lesions immediately after operation;Major adverse cardiovascular events (MACE) event rate;Major adverse cardiovascular and cerebrovascular events (MACCE) event rate;Rate of revascularization;Stent thrombosis rate;Lumen diameter was obtained immediately after operation;Luminal area obtained immediately after operation;Rate of immediate postoperative residual stenosis of target lesions; | — |
Countries
China
Contacts
Public ContactZhang Junjie
Shanghai Huihe Medical Technology Co., LTD
Outcome results
None listed