[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614468":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":40,"centralContacts":45,"locations":56,"responsibleParty":70,"collaborators":74,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":50,"enrollmentInfo":89,"targetDuration":50,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":107,"whyStopped":50,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Beijing Chao Yang Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Rotational Atherectomy + Super High-Pressure Balloon","EXPERIMENTAL","Patients with severely calcified coronary lesions undergo rotational atherectomy followed by super high-pressure balloon angioplasty (SHPB) for calcium modification, then drug-eluting stent implantation with intravascular imaging guidance",[13],"Device: Super High-Pressure Non-Compliant Balloon",{"label":15,"type":16,"description":17,"interventionNames":18},"Rotational Atherectomy + Intravascular Lithotripsy","ACTIVE_COMPARATOR","Patients with severely calcified coronary lesions undergo rotational atherectomy followed by intravascular lithotripsy (IVL) for calcium modification, then drug-eluting stent implantation with intravascular imaging guidance",[19],"Device: Intravascular Lithotripsy System",[21,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Super High-Pressure Non-Compliant Balloon","The super high-pressure balloon is a non-compliant balloon catheter capable of withstanding inflation pressures up to 35-40 atmospheres. The balloon is sized 1:1 to the reference vessel diameter and positioned across the calcified lesion. Inflation follows a stepwise pressure escalation protocol: 12 atm → 20 atm → 25 atm → 30 atm → 35 atm, with each pressure level maintained for 10-20 seconds. The high-pressure inflation creates controlled fractures in calcified plaque to facilitate subsequent stent deployment and expansion. The device is specifically designed for modification of severely calcified coronary lesions.",[9],[27,28,29,30],"SHPB","Ultra-High Pressure Balloon","Non-Compliant Balloon (rated to 35-40 atm)","OPN NC Balloon",{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Intravascular Lithotripsy System","The intravascular lithotripsy (IVL) system is a balloon-based catheter device that delivers sonic pressure waves to fracture calcium in coronary arteries. The IVL balloon is sized 1:1 to the reference vessel diameter and positioned across the calcified lesion. Once inflated to 4 atm, the system delivers up to 80 pulses of localized pulsatile mechanical energy (50 Hz) to create circumferential and longitudinal calcium fractures in both superficial and deep calcium layers. Each treatment cycle consists of 10 pulses over 10 seconds. The device is specifically designed to modify severe coronary calcification to facilitate stent delivery and expansion.",[15],[36,37,38,39],"IVL","Coronary Intravascular Lithotripsy","Sonic Pressure Wave Lithotripsy","Shockwave Coronary IVL System",[41],{"name":42,"affiliation":43,"role":44},"Lin Zhao, Dr","Beijing Chaoyang Hospital, Capital Medical University, Beijing, China","PRINCIPAL_INVESTIGATOR",[46,52],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Xinyue Yang, Dr","CONTACT","+8613592641432",null,"1732583186@qq.com",{"name":53,"role":48,"phone":54,"phoneExt":50,"email":55},"Yuan Fu, Dr","+8613641341747","13641341747@163.com",[57],{"facility":58,"status":50,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":50},"Beijing Chaoyang Hospital，Capital Medical University","Beijing","Beijing Municipality","100020","China","CN",{"type":65,"coordinates":66},"Point",[67,68],116.39723,39.9075,{"lat":68,"lon":67},{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"SPONSOR_INVESTIGATOR","Lin Zhao","Cheif of Cardiovascular department",[75,77],{"name":76,"class":6},"China-Japan Friendship Hospital",{"name":78,"class":6},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine","100614468","comparison-of-ra-ivl-and-ra-shp-in-calcified-coronary-lesions-100614468",false,"NCT07279987","Comparison of RA-IVL and RA-SHP in Calcified Coronary Lesions","Comparison of Combined Rotational Atherectomy With Intravascular Lithotripsy Versus Super-High Pressure Balloon Angioplasty for Heavily Calcified Coronary Lesions (CRUSH-CALC Study)","CRUSH-CALC","Inclusion Criteria:\n\n* Age ≥18 years, able to understand the study purpose and voluntarily sign written informed consent\n* Coronary angiography confirmed severe calcified lesions (Mintz classification ≥Grade 2), with IVUS unable to pass or showing calcification grade ≥2\n* Native coronary artery lesion\n* Target vessel diameter 2.5-4.0mm\n* Lesion length ≤30mm, suitable for rotational atherectomy\n* Clinical indication for PCI: Ischemic cardiomyopathy confirmed by functional testing (e.g., myocardial nuclear scan); Clinical presentation of stable or unstable angina with clear PCI indication\n* Planned rotational atherectomy as initial calcium modification technique\n* After rotational atherectomy (burr diameter ≤1.5mm), IVUS shows calcification grade still ≥2, or \\\u003C2 but 2.5mm non-compliant balloon cannot achieve adequate expansion at nominal pressure\n* Informed consent signed and agreement to participate in clinical trial\n* Able to comply with treatment and complete follow-up\n\nExclusion Criteria:\n\n* Acute myocardial infarction (AMI) within 7 days, as condition may be unstable and increase periprocedural complication risk\n* Target vessel characteristics: Target vessel with thrombus formation, may increase intraoperative embolism risk; Target vessel with chronic total occlusion (CTO), unable to be treated by rotational atherectomy and calcium modification techniques; Target lesion is in-stent restenosis; Target lesion located in coronary artery bypass graft\n* Severe heart failure: left ventricular ejection fraction \\\u003C30%, poor tolerance to PCI surgery, may increase perioperative mortality risk\n* Previous treatment history: previous stent implantation or rotational atherectomy in the same target vessel, as complex lesion structure or confounding treatment effects may exist\n* Special medical history: Known contrast allergy or severe bleeding tendency (such as active gastrointestinal bleeding), may be unable to tolerate PCI surgery; Patients with other serious comorbidities, expected to be unable to complete 12-month follow-up (such as life expectancy \\\u003C12 months)\n* Pregnancy or lactation: pregnant or lactating women, as intraoperative radiation and drug effects may adversely affect mother and child\n* Participation in other clinical trials: patients simultaneously participating in other interventional clinical trials, to avoid mutual influence of different trial intervention measures","ALL","18 Years",{"count":90,"type":91},162,"ESTIMATED","INTERVENTIONAL",[94],"NA","Study Design Prospective, multicenter, single-blind, randomized controlled trial\n\nHypothesis In patients with severely calcified coronary lesions undergoing rotational atherectomy (Rota), post-rotational lesion optimization using intravascular lithotripsy (IVL) is non-inferior to super high-pressure balloon (SHPB) in terms of final minimal lumen diameter (MLD), with potential differences in acute lumen gain, stent expansion, and periprocedural complications.\n\nInclusion Criteria\n\n* Age ≥ 18 years\n* De novo coronary lesions with severe calcification confirmed by angiography (moderate-to-severe calcification) and IVUS (calcification grade ≥2 by Mintz classification, or IVUS cannot pass)\n* Target vessel reference diameter 2.5-4.0 mm\n* Lesion length ≤ 30 mm suitable for rotational atherectomy\n* Clinical evidence of ischemia (stable or unstable angina, or functional ischemia testing)\n* Planned rotational atherectomy with residual calcification grade ≥2 post-Rota (burr ≤1.5 mm), or inadequate expansion with 2.5 mm non-compliant balloon at nominal pressure\n* Written informed consent provided\n\nExclusion Criteria\n\n* Acute myocardial infarction within 7 days\n* Presence of thrombus, chronic total occlusion (CTO), or in-stent restenosis in target vessel\n* Lesion located in coronary artery bypass graft\n* Severe heart failure (LVEF \\\u003C 30%)\n* Previous stenting or rotational atherectomy in same target vessel\n* Known contrast allergy, active bleeding, severe comorbidity with life expectancy \\\u003C 12 months\n* Pregnancy or lactation\n* Participation in other interventional clinical trials\n\nRandomization\n\nAfter initial rotational atherectomy (burr ≤1.5 mm), eligible patients meeting imaging-defined \"need for further lesion optimization\" criteria will be randomized 1:1 to:\n\nRota + IVL group: Intravascular lithotripsy using pulsed ultrasonic energy (up to 80 pulses, 8 cycles) followed by stent implantation Rota + SHPB group: Super high-pressure balloon (≥30 atm) expansion followed by stent implantation Stratification by: Study center, Reference vessel diameter (2.5-3.0 mm vs. \\>3.0-4.0 mm)\n\nPrimary Endpoint Post-procedural minimal lumen diameter (MLD) measured by OCT\u002FIVUS immediately after stent implantation and post-dilation Secondary Endpoints Procedural efficacy: Acute lumen gain, final stent expansion rate, minimal stent area, stent apposition Procedural safety: Periprocedural complications including coronary perforation, dissection, no-reflow\u002Fslow flow, acute stent thrombosis Clinical outcomes: MACE (composite of cardiac death, myocardial infarction, target vessel revascularization) at 30 days, 6 months, and 12 months Other outcomes: Major bleeding (BARC ≥2), acute kidney injury (KDIGO criteria), procedure duration, contrast volume, radiation exposure Sample Size Total: 162 patients (81 per group)\n\nIn-hospital monitoring until discharge Clinical follow-up at 30 days, 6 months, and 12 months Imaging follow-up (OCT\u002FIVUS) selectively at designated centers as per protocol or clinical indication\n\nStudy Centers\n\nThree tertiary hospitals with extensive experience in complex coronary interventions and calcified lesion management:\n\n* Beijing Chaoyang Hospital, Capital Medical University (coordinating center)\n* China-Japan Friendship Hospital\n* Xinhua Hospital, Shanghai Jiao Tong University School of Medicine\n\nStudy Duration January 2026 to December 2028 (3 years)",[97],"Vascular Calcification",[99,100,101,102,103,104,105,106],"Coronary Artery Disease","Percutaneous Coronary Intervention","Vascular calcification","Rotational atherectomy","Intravascular lithotripsy","Super high-pressure balloon","Major adverse cardiovascular events","Plaque modification","NOT_YET_RECRUITING","2025-12-22",{"date":110,"type":111},"2025-12-29","ACTUAL",{"date":113,"type":91},"2026-01-01",{"date":115,"type":91},"2028-12-31",{"name":72,"class":6},1]