Clinical Research Directory

Inclusion Criteria: * Clinical Inclusion criteria: 1. Age ≥18 years; 2. Subject presents with: 1. stable ischemic heart disease or 2. acute coronary syndrome (non-ST-segment elevation myocardial infarction \[NSTEMI\] or unstable angina), or 3. stabilized recent ST-segment elevation myocardial infarction (STEMI) (\>48 hours prior to enrollment); 3. Subject has been fully informed and signed the Institutional Review Board (IRB) approved LOCATION trial Informed Consent Form (ICF) prior to any trial related procedures. * Angiographic inclusion criteria： 1. The reference diameter of each target vessel is ≥2.25 mm and ≤4.0 mm at the lesion site (visual estimation); 2. The target lesion(s) have: <!-- --> 1. A stenosis ≥70% and \<100% (visual estimation), or 2. A stenosis of the target lesion ≥50% and \<70% (visual estimation) with evidence of ischemia via: 1. Positive stress testing (such as single-photon emission computed tomography, echocardiography, treadmill exercise test, etc.), or computed tomography-fractional flow reserve (CT-FFR) value ≤0.80, or; 2. 24-hour Holter electrocardiogram: ST-segment elevation or depression of ≥1 mm in horizontal or down-sloping pattern lasting for at least 1 minute, with an interval of more than 1 minute between two episodes; combined with the patient presenting typical angina symptoms with Canadian Cardiovascular Society grading of angina pectoris II - IV; 3. Pressure wire FFR or angioFFR value ≤0.80 or instantaneous wave-free ratio (iFR) value ≤0.89. 3.The target lesion has fluoroscopic evidence of severe calcium at the lesion site, defined via angiogram as fluoroscopic radiopacities noted without cardiac motion before contrast injection involving both sides of the arterial wall in at least 1 location and total length of calcium of at least 15 mm; All lesions in the non-target vessel, if any, that require treatment are successfully treated without complications prior to randomization, defined as final diameter stenosis ≤20% with final TIMI-3 flow, with no residual dissection grade ≥type B, and no transient or sustained angiographic complications (e.g. distal embolization, side branch closure), no chest pain lasting \>5 minutes, and no ST-segment elevation or depression lasting \>5 minutes. Exclusion Criteria: * Clinical exclusion criteria： 1. Subject has undergone PCI in the target vessel or its branches within 12 months prior to randomization or prior CABG any time; 2. Subject has undergone a PCI procedure in a non-target vessel that is unsuccessful or with complications within 30 days prior to randomization, including during the randomization procedure. Successful and uncomplicated PCI is defined as final diameter stenosis ≤20% with final TIMI-3 flow, no residual dissection grade≥ type B, no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting \>5 minutes, and no ST-segment elevation or depression lasting \>5 minutes); 3. PCI is planned within 12 months post randomization aside from a potential planned staged PCI as part of the randomized treatment strategy; 4. Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), or non-stent treatment only; 5. The investigator believes that based on the angiographic appearance that 1) it is unlikely that an OCT catheter can be delivered; 2) if randomized to no IVL, it is unlikely that the lesion(s) can be crossed and pre-dilated by balloon angioplasty alone; 3) if randomized to IVL, it is unlikely that the IVL catheter can be delivered to the lesion (note: pre-dilatation is allowed if necessary for IVL delivery); 6. Subject has undergone a prior transcatheter or surgical intervention for a non-coronary cardiac condition (e.g. a TAVR or left atrial appendage occlusion) within the prior 6 months, or is anticipated to need such a procedure within 1 year; 7. Subject has severe stenosis or regurgitation of any heart valve, or moderate aortic stenosis or regurgitation; 8. Subject has evidence of heart failure by at least one of the following: <!-- --> 1. Left ventricular ejection fraction (LVEF) ≤30% within 1 month prior to enrollment, or 2. Current heart failure defined as dyspnea with minimal exertion or at rest (NYHA class III or IV within 1 month of the procedure), or 3. Killip class ≥2 for post STEMI patients; 9.Subject is hemodynamically unstable as evidenced by a SBP of \>160 mmHg or \<90 mmHg or a heart rate of \<50 bpm or \>100 bpm (\>110 bpm if in atrial fibrillation) 10.Subjects with known allergy to heparin unless bivalirudin will be used as the procedural anticoagulant; 11.Subjects with known allergy to contrast media that cannot be effectively pre-medicated or any prior anaphylaxis to contrast; 12.Subjects with known allergy to aspirin or both clopidogrel and ticagrelor; 13.History of a stroke within 6 months prior to enrollment, excluding transient ischemic attack (TIA) or any prior intracranial bleed; 14.History of active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to enrollment; 15.Inability to tolerate dual antiplatelet therapy for at least 6 months; 16.Known malignancy or any condition with a life expectancy of ≤12 months; 17.Chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m² or on dialysis; 18.Subject has a history of any cognitive or mental health condition that may interfere with the trial participation including all follow-up visits; 19.Subject is a female who is pregnant (women of child-bearing potential must have a negative pregnancy test within 15 days before the procedure); 20.Subject is participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint. * Angiographic Exclusion Criteria: 1. There are no lesions in any target vessel (main epicardial coronary artery including its side branches) that requires treatment that do not meet all angiographic inclusion criteria; 2. A target lesion is an unprotected LM lesion or an ostial lesion (RCA within 3 mm of the aorta proximal LAD or LCX within 3 mm of the LM); 3. A target lesion is a true bifurcation with a severely calcified side branch that requires treatment but cannot be treated with IVL because of its size, angulation or other condition. A severely calcified side branch is defined via angiogram as fluoroscopic radiopacities noted without cardiac motion before contrast injection involving both sides of the arterial wall) Note: If a true bifurcation target lesion is included, the main branch must be severely calcified; the side branch may or may not be severely calcified. However, if the side branch is severely calcified, it must be eligible for IVL treatment. Otherwise, the final treatment for the side branch may be balloon angioplasty, a DCB or a DES as per the judgement of the operator. The main branch must be treated with a DES. 4. A target lesion is totally occluded (100% diameter stenosis with TIMI flow ≤1); 5. A target lesion contains giant thrombus (defined as angiographic length \>2x the reference vessel diameter); 6. Presence of an aneurysm within 10 mm of the target lesion; 7. Angiographic evidence of severe dissection (type D - F defined by NHLBI classification) in the target lesion prior to device treatment; 8. A target vessel has severe or excessive tortuosity or is deemed unsuitable for angioplasty by investigator judgement; Any intent to perform intravascular imaging during the randomization procedure (unless randomized to OCT).