[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lin Zhao\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":108},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"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":20,"type":21},162,"ESTIMATED","INTERVENTIONAL",[24],"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)",[27],"Vascular Calcification",[29,30,31,32,33,34,35,36],"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":40,"type":41},"2025-12-29","ACTUAL",{"date":43,"type":21},"2026-01-01",{"date":45,"type":21},"2028-12-31",{"name":47,"class":48},"Lin Zhao","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":60,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":49},"100594546","fapi-imaging-predicts-adverse-cardiac-events-in-chronic-total-occlusion-100594546","NCT07020858","FAPI Imaging Predicts Adverse Cardiac Events in Chronic Total Occlusion","The Value of FAPI Imaging for the Prediction of Adverse Cardiovascular Events in Chronic Total Occlusion of Coronary Artery Disease (FACT-2 Trial)","FACT-2","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Confirmed diagnosis of ≥1 untreated chronic total occlusion (CTO):Defined as complete occlusion of a major coronary artery or relevant collateral (reference vessel diameter ≥2.5 mm or confirmed by two independent interventional cardiologists), with TIMI flow grade 0 in the distal segment and duration ≥3 months.Preoperatively confirmed by coronary angiography or coronary computed tomography angiography (CTCA).\n3. Willingness to undergo FAPI-PET imaging and receive PCI under imaging guidance.\n4. Ability to provide written informed consent.\n\nExclusion Criteria:\n\n1. Contraindications to antiplatelet therapy: Allergy or intolerance to aspirin, clopidogrel, or ticagrelor.\n2. Severe liver dysfunction: Liver function parameters exceeding 3× the upper limit of normal.\n3. Severe chronic kidney disease: Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m².\n4. Life expectancy \\\u003C1 year due to non-cardiovascular comorbidities.\n5. Pregnancy or women of childbearing potential (unless surgically sterile or using contraception).",{"count":59,"type":21},470,"2 Years","OBSERVATIONAL","Prospective, observational, single-center cohort study\n\nHypothesis Higher myocardial FAPI uptake in CTO patients predicts a greater incidence of major adverse cardiovascular events (MACE) within 12 months after PCI. FAPI PET\u002FCT imaging is associated with plaque vulnerability features and may serve as a non-invasive marker for fibrotic activity and adverse cardiac remodeling.\n\nInclusion Criteria\n\n* Age ≥ 18 years\n* Presence of at least one untreated chronic total occlusion (CTO) lesion in a major coronary artery (diameter ≥ 2.5 mm, TIMI 0 flow for ≥ 3 months) confirmed by coronary angiography or CTCA\n* Patient eligible for PCI and undergoing FAPI PET\u002FCT imaging prior to intervention\n* Written informed consent provided\n\nExclusion Criteria\n\n* Allergy or contraindication to antiplatelet agents (aspirin, clopidogrel, or ticagrelor)\n* Severe liver dysfunction (liver enzymes \\>3× upper limit of normal)\n* Severe chronic kidney disease (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²)\n* Estimated life expectancy \\\u003C 1 year\n* Pregnancy or potential for pregnancy\n\nPrimary Endpoint Incidence of 1-year MACE, defined as a composite of: Cardiac death, Myocardial infarction, Stroke, Urgent revascularization\n\nSecondary Endpoints\n\n* All-Cause Mortality\n* Death from any cause within 12 months\n* Quality of Life Change: Measured by Seattle Angina Questionnaire (SAQ): changes in angina frequency, physical limitation, and treatment satisfaction\n* Repeat PCI Events: Incidence of: In-stent restenosis (ISR): ≥50% luminal loss in previously stented segment; Target lesion revascularization (TLR): at original PCI lesion; Target vessel revascularization (TVR): other sites in same vessel; De novo lesions: new lesions not previously treated\n\nSample Size Estimated 470 patients\n\nFollow-Up Duration 12 months post-PCI, One follow-up visit including clinical exam, SAQ questionnaire, imaging (PET\u002FCT, echocardiography), and laboratory testing.",[64,65],"Chronic Total Occlusion (CTO)","Chronic Coronary Syndrome",[67,68,69,70,71,72],"Coronary Heart Disease","Major adverse cardiovascular events (MACE)","Plaque vulnerability","Optical coherence tomography (OCT)","Fibroblast activation protein inhibitor (FAPI)","Percutaneous coronary intervention (PCI)","RECRUITING","2025-06-16",{"date":76,"type":41},"2025-06-19",{"date":78,"type":41},"2025-04-15",{"date":80,"type":21},"2027-03-15",{"name":47,"class":48},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":60,"studyType":61,"phases":4,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100566495","fapi-imaging-assessment-of-chronic-total-occlusion-100566495","NCT06655922","FAPI Imaging Assessment of Chronic Total Occlusion","The Clinical Value of FAPI Imaging in Assessing Chronic Total Occlusion Lesions in Patients with Coronary Heart Disease (FACT Trial)","FACT","Inclusion Criteria:\n\n* Age \\> 18 years\n* Presence of at least one untreated CTO at basal angiography (defined as a total occlusion in any major coronary vessel or relevant side branches \\[reference vessel diameter ≥2.5mm or as judged by two independent interventional cardiologists\\], with TIMI 0 in the distal segment and at least 3 months old\n* Patient has a clinical indication to perform CTO PCI\n* Willing to participate and able to understand, read and sign the informed consent document.\n\nExclusion Criteria:\n\n* Hypersensitivity to aspirin, clopidogrel, or -limus families \u002F or contraindication to antiplatelet agents\n* Severe hepatic dysfunction (≥3 times normal reference values)\n* Severe chronic kidney disease (estimated Glomerular Filtration Rate \\[eGFR\\] \\<30 mL\u002Fmin\u002F1.73m2)\n* Life expectancy \\< 1 years\n* Pregnant women or women with potential childbearing",{"count":91,"type":21},167,"This registry will include consecutive patients presenting with at least one chronic total coronary occlusion (CTO) identified via coronary angiography or cardiac computed tomography angiography (CCTA) at our center. Due to the complexity of CTO lesions, both procedural success rates and prognosis improvements are limited. The progression and development of atherosclerotic plaques involve fibroblast activity, contributing to the formation of fibrous caps and calcified nodules through various mechanisms. Myocardial fibrosis within chronically occluded segments is strongly linked to ventricular remodeling and patient prognosis. The activation of cardiac fibroblasts (CFs) is a critical early phase in myocardial fibrosis, playing a key role in fibrotic progression. However, the role of activated CFs in CTO patients has remained unclear, mainly due to the lack of reliable in vivo assessment techniques for detecting CF activation.\n\nRecent studies have demonstrated that radionuclide-labeled fibroblast activation protein inhibitor (FAPI) imaging is an effective and reliable technique for detecting both myocardial fibrosis and activated CFs in arterial plaques. Preliminary data suggest that FAPI imaging can characterize plaque composition and assess the extent of myocardial fibrosis in various cardiovascular conditions. However, its potential to predict the ease of CTO recanalization and subsequent clinical outcomes remains to be fully explored.\n\nThe aim of this prospective cohort study is to evaluate the predictive value of FAPI imaging in patients with at least one untreated CTO. All enrolled patients will undergo baseline assessments prior to intervention, including blood tests, clinical evaluations, and imaging studies. These imaging studies will include myocardial FDG\u002Fperfusion imaging, FAPI imaging, and resting perfusion imaging. In selected patients, additional evaluations such as stress myocardial perfusion imaging, magnetic resonance imaging (MRI), and echocardiography will also be performed.\n\nFor patients undergoing percutaneous coronary intervention (PCI), follow-up assessments will occur at 6 and 12 months. At the 6-month mark, improvements in left ventricular (LV) wall motion will be assessed using resting perfusion imaging. At 12 months, coronary angiography (CAG) will be performed on all patients to evaluate recanalization outcomes. Additionally, myocardial perfusion imaging, magnetic resonance imaging (MRI), and echocardiography may be selectively used to evaluate patients during the 12-month follow-up.\n\n1. To evaluate the ability of FAPI imaging in predicting the difficulty of CTO recanalization.\n2. To investigate the role of myocardial FAPI imaging in predicting the improvement of LV wall motion at 6 months, assessed using follow-up single-photon emission computed tomography (SPECT).\n\nBy comparing FAPI imaging with conventional prognostic assessment methods, this study aims to clarify the utility of FAPI imaging in both predicting the recanalization complexity and in assessing long-term clinical outcomes in CTO patients.",[64],[67,95,96,97,98],"Fibroblast activation protein inhibitor","Percutaneous coronary intervention","Imaging","Prognosis","2024-10-22",{"date":101,"type":41},"2024-10-24",{"date":103,"type":41},"2024-09-10",{"date":105,"type":21},"2026-08-31",{"name":47,"class":48},2,""]