Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus
Coronary Artery Disease, Intravascular Lithotripsy
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: Age 18-80 years, male or non-pregnant female. Evidence of symptomatic ischemia, stable or unstable angina, or MI for more than 7 days. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to undergo angiography, OCT and clinical follow-up. Angiogram inclusion criteria The target lesion was primary and in situ coronary artery disease. Target lesion length ≤40 mm, target lesion reference vessel diameter 2.25-4.0 mm (visual inspection). The target lesion diameter stenosis ≥70% or ≥50% (visual inspection) with evidence of ischemia. Clear, high-density shadows can be seen both when the heart is beating and when it is not. TIMI flow grade 3(allowing predilation) in the target vessel before use of the test equipment. The target lesion was the only calcified lesion to be treated with the shock wave, and the non-target lesion needed to be treated successfully before the target lesion. Suitable for patients undergoing metallic stent implantation Exclusion Criteria: Severe myocardial infarction occurred within 7 days before operation. At the same time, the lesions were treated with rotational grinding or special balloon (chocolate balloon, nicked balloon, cutting balloon, double guide wire balloon, spinous process balloon, etc.). NYHA Class III or IV. Left ventricular ejection fraction <35% . The target lesion was expected to be treated by fully biodegradable stent implantation, drug balloon dilatation and PTCA. Uncontrollable severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure > 110 mmHg). Severe hepatic and renal impairment, transaminase more than 3 times the upper limit of normal, serum creatinine > 2.5 mg/dL (221 μmol/L), or chronic kidney failure requiring long-term dialysis. Preoperative hemoglobin <100 g/l. Platelet count <60×109/L. Cerebral Stroke occurred within 6 months of enrollment, excluding transient ischemic attack (TIA) and lacunar infarction. A history of active peptic ulcer or upper gastrointestinal bleeding within 6 months before enrollment. Patients known to be allergic to heparin, contrast media, aspirin, clopidogrel and anesthetics. Definite diagnosis of malignancy or life expectancy would be less than 12 months. Participation in clinical trials of other drugs or medical devices that did not reach the primary end point. The researchers judged that the patients had poor compliance and could not complete the study according to the protocol. Angiographic exclusion criteria: The target lesion was in the opening position (LAD, LCX or RCA, within 5 mm of the opening) or unprotected left main coronary artery. Stents were implanted 10mm proximal or distal to the target lesion. The target lesion had unprotected branch vessels more than 2.5mm in diameter. The target lesion was distal to the saphenous vein or LIMA (Left internal mammary artery) /RIMA (Right internal mammary artery) bypass graft. Existed an aneurysm within 10mm of the target lesion. Angiography confirmed the presence of severe target lesion dissection (type D-F dissection (NHLBI classification) before the treatment of the Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus The target lesion had definite thrombosis. The researchers determined that the target lesion was unsuitable for vasodilation in patients.
Sites / Locations
- Southern Medical University Nanfang HospitalRecruiting
- Meizhou People's HospitalRecruiting
- Cangzhou Central HospitalRecruiting
- the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force
- Fuwai Huazhong Cardiovascular Hospital
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- People's Hospital of Wuhan University
- The First Hospital of Jilin UniversityRecruiting
- The Second Hospital of Jilin University
- The First Affiliated Hospital of Dalian Medical University
- General Hospital of Northern Theater CommandRecruiting
- General Hospital of Ningxia Medical UniversityRecruiting
- Second Hospital of Shanxi Medical University
- Shanxi Cardiovascular HospitalRecruiting
- West China Hospital of Sichuan UniversityRecruiting
- Beijing Jishuitan HospitalRecruiting
- Peking University People's Hospital
- Beijing Tsinghua Chang Gung HospitalRecruiting
- Tianjin Chest HospitalRecruiting
- TEDA International Cardiovascular Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Experimental group
Optical Coherence Tomography Subgroup
184 patients were enrolled in the experimental group
70 patients in the test group were enrolled in the OCT subgroup.