[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659450":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":22,"studyPopulation":11,"armGroups":23,"interventions":34,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":42,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":11,"overallStatus":67,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":11},{"fullName":5,"class":6},"Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Composite incidence of major adverse events (MAE) within 48 hours after the procedure",null,"within 48 hours post-procedure",{"measure":14,"description":11,"timeFrame":15},"Change in the RV\u002FLV diameter ratio from baseline to 48 hours (ΔRV\u002FLV) measured by CTPA core laboratory","baseline and 48 hours",{"allocation":17,"interventionModel":18,"interventionModelDescription":11,"primaryPurpose":19,"observationalModel":11,"timePerspective":11,"maskingInfo":20},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":21,"maskingDescription":11,"whoMasked":11},"NONE","Acute PE is the third leading cause of cardiovascular death, and patients with intermediate-high risk PE-hemodynamically stable but with imaging-confirmed right ventricular dysfunction and elevated cardiac injury biomarkers-are at substantial risk of early deterioration. PMT with large-bore catheters enables immediate thrombus removal and hemodynamic recovery without systemic thrombolytic exposure, whereas CDT delivers low-dose thrombolytics locally to dissolve residual thrombus with a reduced systemic bleeding risk. Combining PMT with low-dose CDT (PMT+LDCDT) may improve thrombus clearance without a meaningful increase in bleeding. This prospective, multicenter cohort study will enroll approximately 150 patients with acute intermediate-high risk PE at centers with pulmonary vascular interventional capability. Patients will be allocated to PMT alone or PMT+LDCDT according to the operator's pre- and intra-procedural assessment. Participants will be followed at 24 h, 48 h, 7 days\u002Fdischarge, 30 days, 90 days, 6 months and 12 months. The study will evaluate safety (48-hour MAE composite: all-cause death, intracranial hemorrhage, ISTH major bleeding and other major adverse events) and efficacy (change in RV\u002FLV diameter ratio from baseline to 48 hours by CTPA core laboratory), as well as thrombus clearance, procedure time, length of stay, and the incidence of chronic thromboembolic pulmonary hypertension (CTEPH) at 6 and 12 months.",[24,29],{"label":25,"type":26,"description":25,"interventionNames":27},"PMT alone (percutaneous mechanical thrombectomy only)","ACTIVE_COMPARATOR",[28],"Device: PMT alone (percutaneous mechanical thrombectomy only)",{"label":30,"type":31,"description":30,"interventionNames":32},"PMT plus low-dose catheter-directed thrombolysis (PMT+LDCDT)","EXPERIMENTAL",[33],"Device: PMT plus low-dose catheter-directed thrombolysis (PMT+LDCDT)",[35,39],{"type":36,"name":25,"description":37,"armGroupLabels":38,"otherNames":11},"DEVICE","Percutaneous mechanical thrombectomy system (e.g., FlowTriever, Indigo aspiration system)",[25],{"type":36,"name":30,"description":40,"armGroupLabels":41,"otherNames":11},"Low-dose catheter-directed thrombolysis: Alteplase (rt-PA), ≤20 mg (≤10 mg per lung), infused over ≤30 min via pulmonary artery catheter",[30],{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Qiu Jipeng","Physician","100659450","percutaneous-mechanical-thrombectomy-with-or-without-low-dose-catheter-directed-thrombolysis-in-acute-intermediate-high-risk-pulmonary-embolism-100659450",false,"NCT07865572","Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism","A Prospective Cohort Study Comparing Percutaneous Mechanical Thrombectomy Alone Versus Percutaneous Mechanical Thrombectomy Combined With Low-Dose Catheter-Directed Thrombolysis in the Treatment of Acute Intermediate-High Risk Pulmonary Embolism","PMT-LDCDT-PE","Inclusion Criteria:\n\n* Age 18-80 years.\n* Acute pulmonary embolism confirmed by CTPA, with symptom onset to diagnosis ≤14 days.\n* Imaging evidence of right ventricular dysfunction (CTPA RV\u002FLV diameter ratio ≥1.0, or echocardiographic right ventricular dilation\u002Fhypokinesia) and elevated cardiac injury biomarkers (troponin I or T above the upper limit of normal).\n* Presence of a contraindication to systemic thrombolysis, or failure of systemic thrombolysis, or clinical deterioration during anticoagulation.\n* Thrombus visible in the main pulmonary artery and\u002For lobar arteries on CTPA.\n* Provision of signed informed consent.\n\nExclusion Criteria:\n\n* Cardiac arrest at enrollment; systolic blood pressure \\\u003C80 mmHg for \\>15 minutes unresponsive to fluid resuscitation and vasopressors.\n* Active bleeding; known coagulopathy (INR \\>2.0 or platelet count \\\u003C50×10⁹\u002FL); intracranial hemorrhage within 90 days, or intracranial tumor\u002Fvascular malformation; major surgery, major trauma, or stroke within 30 days.\n* Known heparin allergy or a history of heparin-induced thrombocytopenia.\n* Prior systemic thrombolytic therapy.\n* Known chronic thromboembolic pulmonary hypertension (CTEPH); severe left ventricular dysfunction (LVEF \\\u003C30%); severe valvular heart disease; end-stage renal disease (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²); pregnancy or lactation.\n* Intracardiac or intrapulmonary mass on CTPA; severe stenosis or occlusion of the inferior vena cava or iliofemoral vein.\n* CTPA image quality inadequate for independent core laboratory interpretation.\n* Current participation in another clinical study that could interfere with endpoint assessment.",true,"ALL","18 Years","80 Years",{"count":59,"type":60},150,"ESTIMATED","INTERVENTIONAL",[63],"NA","Acute pulmonary embolism (PE) is the third most common cardiovascular cause of death. In patients with intermediate-high risk acute PE, percutaneous mechanical thrombectomy (PMT) using large-bore catheters achieves rapid hemodynamic improvement while avoiding the bleeding risk of systemic thrombolysis, and low-dose catheter-directed thrombolysis (CDT) can dissolve residual thrombus with a lower systemic bleeding risk. This prospective, multicenter, non-randomized cohort study aims to compare the safety and efficacy of PMT alone versus PMT combined with low-dose CDT (PMT+LDCDT) in patients with acute intermediate-high risk PE. Approximately 150 patients will be enrolled and allocated to either PMT alone or PMT+LDCDT based on operator assessment. The primary safety endpoint is the composite incidence of major adverse events (MAE) within 48 hours, and the primary efficacy endpoint is the change in the right ventricular\u002Fleft ventricular (RV\u002FLV) diameter ratio from baseline to 48 hours assessed by a CTPA core laboratory.",[66],"Acute Pulmonary Embolism","NOT_YET_RECRUITING","2026-10-04",{"date":70,"type":71},"2026-10-08","ACTUAL",{"date":73,"type":60},"2026-10-01",{"date":75,"type":60},"2031-12-31",{"name":44,"class":6}]