[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659921":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":22,"studyPopulation":11,"armGroups":23,"interventions":40,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":54,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":11,"overallStatus":78,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"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 Major Adverse Events Within 7 Days After the Procedure",null,"7 days after the index procedure",{"measure":14,"description":11,"timeFrame":15},"Change in Right Ventricular to Left Ventricular (RV\u002FLV) Diameter Ratio on CTPA From Baseline to 48 Hours After the Procedure","Baseline and 48 hours after the index procedure",{"allocation":17,"interventionModel":18,"interventionModelDescription":11,"primaryPurpose":19,"observationalModel":11,"timePerspective":11,"maskingInfo":20},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":21,"maskingDescription":11,"whoMasked":11},"NONE","Background Acute pulmonary embolism (PE) is the third leading cause of cardiovascular death worldwide. Patients with intermediate-high-risk PE are haemodynamically stable but have imaging evidence of right ventricular dysfunction and elevated cardiac biomarkers, and remain at risk of early clinical deterioration. Anticoagulation alone may be insufficient to reduce thrombus burden, whereas systemic thrombolysis carries a substantial risk of major bleeding. Percutaneous catheter-based therapy has therefore become an important treatment option. Current aspiration catheters fall into two categories: small-bore systems (8-12 F), which are highly trackable into distal pulmonary artery branches but less efficient at removing large central thrombus, and large-bore systems (16 F or larger), which remove central thrombus efficiently but may be difficult to advance into distal vessels. A combined strategy, using a large-bore catheter first for central thrombus and a small-bore catheter subsequently for residual distal thrombus, is used in clinical practice, but its safety and effectiveness have not been systematically evaluated in a prospective study.\n\nObjective This multicentre prospective observational cohort study will compare the safety and short-term effectiveness of three catheter-based aspiration strategies in adults with intermediate-high-risk acute PE: small-bore aspiration alone, large-bore aspiration alone, and combined large-bore plus small-bore aspiration.\n\nStudy design\n\nConsecutive patients scheduled to undergo percutaneous catheter aspiration thrombectomy as part of routine care at five participating hospitals in China are screened and enrolled after providing written informed consent. Participants are assigned to one of three cohorts according to the catheter strategy actually used during the index procedure; the strategy is selected by the treating physician according to routine clinical practice and is not allocated by the study protocol.\n\nData collection Baseline demographic, clinical, laboratory, CTPA, and echocardiographic data are collected before the procedure. Procedural data include angiographic findings, technique used, procedure and fluoroscopy times, and intraoperative blood loss. Clinical assessments are performed at 24 hours, 48 hours, and 7 days (or before discharge), with follow-up visits (clinic or telephone) at 30 +\u002F- 7 days and 90 +\u002F- 14 days. All imaging and laboratory tests are performed as part of standard care; the study requires no additional invasive procedures or examinations.\n\nCo-primary endpoints\n\n(1) The composite rate of major adverse events within 7 days after the procedure. (2) The change in the right ventricular to left ventricular (RV\u002FLV) diameter ratio on CTPA from baseline to 48 hours after the procedure, measured by an independent core laboratory.\n\nStatistical analysis Approximately 225 participants will be enrolled (about 75 per cohort). The co-primary effectiveness endpoint will be analysed by analysis of covariance adjusted for baseline RV\u002FLV ratio; the composite safety endpoint will be analysed using logistic regression or Cox proportional hazards models. Non-inferiority of the combined strategy versus large-bore aspiration alone will be assessed for the composite major adverse event endpoint, with a pre-specified non-inferiority margin of 8%, together with a superiority assessment for the change in RV\u002FLV ratio. Baseline imbalances will be addressed by multivariable regression and, as sensitivity analyses, by propensity score matching or inverse probability of treatment weighting. Subgroup analyses by risk category, thrombus distribution, age, sPESI, and VTE-BLEED score, and multiplicity adjustment using Bonferroni or Benjamini-Hochberg methods, are pre-specified. Missing primary endpoint data will be handled by multiple imputation. An independent data and safety monitoring board will perform an interim safety review when 50% of the planned enrolment is reached.\n\nExpected impact The results are expected to inform clinical selection of aspiration catheter size and strategy in intermediate-high-risk acute PE, and to support standardisation of percutaneous interventional management.",[24,30,35],{"label":25,"type":26,"description":27,"interventionNames":28},"Small-Bore Catheter Aspiration Group","ACTIVE_COMPARATOR","Participants treated with a small-bore (8-12 F) percutaneous aspiration catheter system alone during the index procedure, as selected by the treating physician according to routine clinical practice.",[29],"Device: Small-bore (8-12 F) percutaneous catheter aspiration",{"label":31,"type":26,"description":32,"interventionNames":33},"Large-Bore Catheter Aspiration Group","Participants treated with a large-bore (16 F or larger) percutaneous aspiration\u002Fmechanical thrombectomy system alone during the index procedure, as selected by the treating physician according to routine clinical practice.",[34],"Device: Large-bore (16 F or larger) percutaneous catheter aspiration thrombectomy",{"label":36,"type":26,"description":37,"interventionNames":38},"Combined Large-Bore Plus Small-Bore Catheter Aspiration Group","Participants treated sequentially with a large-bore catheter to remove central thrombus followed by a small-bore catheter to address residual distal thrombus during the index procedure, as selected by the treating physician according to routine clinical practice.",[39],"Device: Combined large-bore and small-bore percutaneous catheter aspiration",[41,46,50],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":11},"DEVICE","Small-bore (8-12 F) percutaneous catheter aspiration","Continuous or intermittent vacuum aspiration through a small-bore (8-12 F) catheter positioned in the pulmonary arteries to remove thrombus. Catheter selection, access site, and aspiration technique follow the treating centre's standard practice.",[25],{"type":42,"name":47,"description":48,"armGroupLabels":49,"otherNames":11},"Large-bore (16 F or larger) percutaneous catheter aspiration thrombectomy","Mechanical aspiration-thrombectomy using a large-bore (16 F or larger) catheter system positioned in the pulmonary arteries to remove central thrombus. Device selection and technique follow the treating centre's standard practice.",[31],{"type":42,"name":51,"description":52,"armGroupLabels":53,"otherNames":11},"Combined large-bore and small-bore percutaneous catheter aspiration","Sequential use of a large-bore (16 F or larger) catheter to debulk central thrombus, followed by a small-bore (8-12 F) catheter to aspirate residual distal thrombus within the same procedure.",[36],{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Qiu Jipeng","Physician","100659921","comparing-three-catheter-aspiration-strategies-for-intermediate-high-risk-acute-pulmonary-embolism-100659921",false,"NCT07869875","Comparing Three Catheter Aspiration Strategies for Intermediate-High-Risk Acute Pulmonary Embolism","Safety and Effectiveness of Different-Size Percutaneous Catheter Aspiration Strategies in Patients With Intermediate-High-Risk Acute Pulmonary Embolism: A Prospective, Multicentre, Open-Label Observational Cohort Study","Inclusion Criteria:\n\n* Age 18 to 80 years.\n* Acute pulmonary embolism confirmed by computed tomography pulmonary angiography (CTPA).\n* Interval from symptom onset to diagnosis of 14 days or less.\n* Intermediate-high-risk PE according to the 2025 Chinese guideline and ESC risk stratification: simplified Pulmonary Embolism Severity Index (sPESI) of 1 or greater; imaging evidence of right ventricular dysfunction (CTPA RV\u002FLV diameter ratio \\>= 1.0, or echocardiographic right ventricular dilatation or hypokinesia); and troponin I or T above the upper limit of normal.\n* Eligible for percutaneous catheter-directed intervention: contraindication to, or failure of, systemic thrombolysis, or clinical deterioration during anticoagulation therapy.\n* Thrombus visible in the main pulmonary artery and\u002For lobar arteries on CTPA.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Haemodynamic instability at enrolment: cardiac arrest; need for ongoing cardiopulmonary resuscitation; or systolic blood pressure below 80 mmHg for more than 15 minutes unresponsive to fluid resuscitation and vasopressors.\n* Active bleeding; known coagulopathy (INR \\> 2.0 or platelet count \\\u003C 50 x 10\\^9\u002FL); intracranial haemorrhage within the previous 90 days, or intracranial tumour or vascular malformation; major surgery, major trauma, or gastrointestinal bleeding within the previous 30 days; known heparin allergy or history of heparin-induced thrombocytopenia.\n* Planned catheter-directed thrombolysis or systemic thrombolysis.\n* Known chronic thromboembolic pulmonary hypertension; severe left ventricular dysfunction (LVEF \\\u003C 30%); severe valvular heart disease (moderate-to-severe aortic stenosis or mitral regurgitation); end-stage renal disease (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 or dialysis dependence); pregnancy or breastfeeding.\n* Anatomical contraindications: intracardiac or pulmonary arterial mass on CTPA or ultrasound suggesting tumour or infective embolus; severe stenosis or occlusion of the inferior vena cava or the iliofemoral venous route.\n* CTPA image quality inadequate for independent core laboratory reading.\n* Expected survival of less than 6 months due to severe comorbidity (for example, advanced malignancy); inability or unwillingness to complete the follow-up schedule.\n* Participation in another clinical study that could interfere with endpoint assessment; any other condition that, in the investigator's judgement, makes participation inappropriate.",true,"ALL","18 Years","80 Years",{"count":70,"type":71},225,"ESTIMATED","INTERVENTIONAL",[74],"NA","Acute pulmonary embolism (PE) is a serious and potentially life-threatening condition in which blood clots block the arteries of the lungs. For patients with intermediate-high-risk PE, doctors may remove the clots through a thin tube (catheter) placed into the lung arteries, a procedure called percutaneous catheter aspiration.\n\nTwo main types of catheters are used. Small-bore catheters (8-12 French) are easier to guide into the smaller, more distant branches of the lung arteries, but they remove large central clots less efficiently. Large-bore catheters (16 French or larger) remove central clots more effectively, but are harder to advance into the smaller branches. Some doctors use both types together, starting with a large-bore catheter for the central clot and then a small-bore catheter for the remaining distal clot. It is not yet known which of these three approaches is safest and works best.\n\nThis study will follow about 225 adults with intermediate-high-risk acute PE who are treated with catheter aspiration at five hospitals in China. Participants are grouped according to the catheter strategy that was actually used during their routine care: small-bore aspiration only, large-bore aspiration only, or combined large-bore plus small-bore aspiration. Information is collected from routine hospital tests, CT scans, echocardiograms, procedure records, and follow-up visits at 24 hours, 48 hours, 7 days, 30 days, and 90 days after the procedure. The study does not require any extra invasive tests or procedures.\n\nThe main goals are to compare, among the three groups: (1) the rate of major adverse events within 7 days after the procedure, and (2) the improvement in right-heart strain seen on CT scans 48 hours after the procedure. The results may help doctors choose the most suitable catheter strategy for patients with intermediate-high-risk acute PE.",[77],"Acute Pulmonary Embolism","NOT_YET_RECRUITING","2026-10-08",{"date":81,"type":82},"2026-10-13","ACTUAL",{"date":84,"type":71},"2026-10-04",{"date":86,"type":71},"2031-12-31",{"name":56,"class":6}]