bm shockwave devices clinical study in coronary calcified lesions

Conditions: Coronary Artery Disease

Summary: this clinical trial is a prospective, multicenter, single-arm, target-value study to verify the safety and efficacy of bm coronary shockwave devices for the treatment of coronary calcification lesions.


Eligibility criteria:
inclusion criteria: * general inclusion criteria: 1. age 18-85 years, male or female; 2. patients with evidence of asymptomatic ischemia, stable or unstable angina, or old myocardial infarction; 3. patient is able and willing to comply with all assessments in the study. angiography inclusion criteria: 1. the target lesion is a de novo, in-situ coronary artery lesion; 2. the target lesion length is ≤40 mm, and the target lesion reference vessel diameter is 2.0-4.0 mm (visual estimation); 3. the target lesion diameter stenosis is visually estimated to be ≥70%, or \<70% but ≥50% with evidence of ischemia; 4. clear high-density calcification shadows are visible both during cardiac contraction and at rest; 5. target vessel timi flow grade 3 prior to use of the investigational device (pre-dilatation is permitted); 6. the target lesion is the only calcified lesion to be treated with shock wave therapy in this session; if non-target lesions are present, they must be successfully treated prior to the target lesion; 7. patients suitable for treatment with metal stent implantation. exclusion criteria: * general exclusion criteria: 1. st-segment elevation myocardial infarction within 3 days prior to the procedure; 2. use of rotational atherectomy or special balloons (chocolate balloon, scoring balloon, cutting balloon, etc.) for lesion pretreatment; 3. new york heart association (nyha) functional class iii or iv; 4. target lesion expected to require full biodegradable scaffold implantation, drug-eluting balloon dilation, or percutaneous transluminal coronary angioplasty (ptca) treatment; 5. uncontrolled severe hypertension (persistent: systolic blood pressure \>180 mmhg or diastolic blood pressure \>110 mmhg); 6. severe liver or kidney dysfunction, with transaminase levels exceeding three times the upper limit of normal, serum creatinine \>2.5 mg/dl (221 μmol/l), or chronic kidney failure requiring long-term dialysis; 7. platelet count \<60 × 10⁹/l; 8. stroke within the past 6 months prior to enrollment, excluding transient ischemic attack (tia) and lacunar infarction; 9. active peptic ulcer or history of upper gastrointestinal bleeding within the past 6 months prior to enrollment; 10. known allergy to heparin, contrast agents, aspirin, clopidogrel, or anesthetics; 11. patients with a life expectancy of less than 12 months due to severe medical conditions; 12. patients who have participated in other drug or device clinical trials and failed to meet the primary endpoint; 13. pregnant or breastfeeding women; 14. patients deemed by the investigator to have poor compliance and unable to complete the study according to the protocol. contrast exclusion criteria: 1. the target lesion and non-target lesion are in the same vascular branch; 2. the target lesion is at the origin (lad, lcx, or rca, within 5 mm of the origin) or an unprotected left main lesion; 3. a stent has been implanted within 10 mm of the proximal or distal end of the target lesion; 4. the target lesion has an unprotected branch vessel with a diameter of 2.5 mm or greater; 5. the target lesion is located distal to the saphenous vein or lima (left internal mammary artery)/rima (right internal mammary artery) bypass graft; 6. an aneurysm is present within 10 mm of the target lesion; 7. contrast imaging confirms the presence of an nhlbi classification d-f type arterial dissection at the target lesion prior to the use of the investigational device; 8. the target lesion has definite thrombus formation; 9. the investigator determines that the target lesion is not suitable for vascular dilation in the patient.

Keywords: coronary artery disease shockwave therapy coronary calcified lesions