[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595405":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":30,"collaborators":11,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":11,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":43,"enrollmentInfo":44,"targetDuration":11,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":57,"whyStopped":11,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":11},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Innovative Device Group: Minimally invasive thrombectomy","EXPERIMENTAL",null,[13],"Procedure: Innovative Device Group",{"label":15,"type":16,"description":11,"interventionNames":17},"Standard Pharmacological Therapy Group: Pharmacological thrombolysis + anticoagulation","ACTIVE_COMPARATOR",[18],"Drug: Standard Pharmacological Therapy Group",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","Innovative Device Group","Catheter-based thrombectomy is performed within 4 hours after baseline CTPA acquisition. Pre-procedural anticoagulation with either low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) is administered prior to thrombectomy. Post-procedural oral anticoagulation is transitioned to rivaroxaban 20 mg once daily (QD).",[9],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"DRUG","Standard Pharmacological Therapy Group","Following thrombolytic agent administration, anticoagulation with rivaroxaban is initiated and maintained at 15 mg twice daily (BID) for the initial 3 weeks, then switched to 20 mg once daily (QD) thereafter.",[15],{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Jun Pu","Professor, Chief Physician","100595405","early-phase-1-mechanical-thrombectomy-for-acute-pulmonary-embolism-100595405",false,"NCT07032025","Mechanical Thrombectomy for Acute Pulmonary Embolism","A Prospective, Multicenter, Randomized Controlled Trial of the Catheter-directed Mechanical Thrombectomy Compared to Standard Anticoagulation for Use in the Treatment of Acute Intermediate-risk Pulmonary Embolism.","Inclusion Criteria:\n\n* Aged 18-75 years (male or female)\n* Clinically diagnosed with acute PE\n* Right ventricular\u002Fleft ventricular diameter ratio (RV\u002FLV) ≥0.9 on computed tomographic pulmonary angiography (CTPA)\n* Provision of voluntary written informed consent.\n\nExclusion Criteria:\n\n* Target vessel diameter \\\u003C6 mm\n* Calcification, plaque, or stenosis in target lesion\n* Sustained systolic blood pressure \\\u003C90 mmHg for \\>15 minutes or requiring vasopressors to maintain SBP ≥90 mmHg\n* Peak pulmonary artery pressure \\>70 mmHg\n* Hematocrit \\\u003C28%\n* History of chronic pulmonary hypertension\n* Pre-existing left bundle branch block\n* Chronic left heart failure with left ventricular ejection fraction (LVEF) ≤30%\n* Renal dysfunction (serum creatinine \\>1.8 mg\u002FdL or \\>159 μmol\u002FL)\n* Known coagulopathy or bleeding diathesis:\n\nPlatelet count \\\u003C50×10⁹\u002FL, or International Normalized Ratio (INR) \\>3\n\n* Contraindications to antiplatelet\u002Fanticoagulant therapy\n* Cardiothoracic or pulmonary surgery within 7 days prior\n* Intracardiac thrombus\n* Patients on extracorporeal membrane oxygenation (ECMO)\n* Known hypersensitivity to iodinated contrast media\n* Significant comorbidities complicating treatment\u002Fevaluation:\n\nActive malignancy Acute infectious disease\u002Fsepsis Systemic conditions precluding procedure tolerance Life expectancy \\\u003C1 year\n\n* Pregnant or lactating women\n* Concurrent participation in other drug\u002Fdevice trials\n* Other investigator-determined unsuitability","ALL","18 Years","75 Years",{"count":45,"type":46},200,"ESTIMATED","INTERVENTIONAL",[49],"EARLY_PHASE1","Research Objective:\n\nTo prospectively compare the efficacy and safety of a pre-collaboratively developed ultra-thin PTFE minimally invasive thrombectomy system versus standard pharmacological therapy in patients with acute pulmonary embolism (PE), both administered on top of standard care.\n\nResearch Content:\n\nPatients meeting all the following criteria will be enrolled:\n\nAged 18-75 years (male or female)\n\nClinically diagnosed with acute PE\n\nRight ventricular\u002Fleft ventricular diameter ratio (RV\u002FLV) ≥0.9 on computed tomographic pulmonary angiography (CTPA)\n\nProvision of voluntary written informed consent.\n\nStudy Design:\n\nAfter confirming eligibility, subjects will be randomized at a 1:1 ratio into two groups:\n\nInnovative Device Group: Minimally invasive thrombectomy\n\nStandard Pharmacological Therapy Group: Pharmacological thrombolysis + anticoagulation\n\nStudy Endpoints:\n\nPrimary Efficacy Endpoint:\n\nReduction in RV\u002FLV ratio (measured by CTPA) from baseline to 48 hours post-treatment.\n\nPrimary Safety Endpoint:\n\nIncidence of Major Adverse Events (MAEs) from baseline to 48 hours post-treatment, defined as:\n\nProcedure-related death\n\nMajor bleeding (per VARC-2 criteria: life-threatening, disabling, or major bleeding)\n\nTreatment-related clinical deterioration, including:\n\nUnplanned mechanical ventilation\n\nArterial hypotension (systolic blood pressure \\\u003C90 mmHg for \\>1 hour or requiring vasopressors) or shock\n\nCardiopulmonary resuscitation\n\nSustained deterioration in oxygenation\n\nEmergency surgical embolectomy.\n\nKey Terminology Notes:\n\nRV\u002FLV: Right Ventricular\u002FLeft Ventricular diameter ratio (standard medical abbreviation retained).\n\nVARC-2: Valve Academic Research Consortium-2 (internationally recognized bleeding criteria).\n\nPTFE: Polytetrafluoroethylene (material name preserved).\n\nMAE: Major Adverse Events (acronym defined at first use).\n\nClinical deterioration: Explicitly specified with objective clinical indicators.\n\nThis translation maintains scientific precision while adhering to international clinical trial reporting standards (ICH-GCP). The structure aligns with typical English-language study protocols for clarity and reproducibility.",[52],"Acute Pulmonary Embolism",[54,55,56],"Prospective Studies","Pulmonary Embolism","Thrombectomy","NOT_YET_RECRUITING","2025-06-13",{"date":60,"type":61},"2025-06-22","ACTUAL",{"date":63,"type":46},"2025-07-01",{"date":65,"type":46},"2027-07-01",{"name":5,"class":6}]