[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627773":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":38,"responsibleParty":77,"collaborators":20,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":20,"enrollmentInfo":90,"targetDuration":20,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":40,"whyStopped":20,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"National Medical Research Center for Cardiology, Ministry of Health of Russian Federation","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Safety and clinical efficacy of EKOS in intermediate-high risk patients with PE","EXPERIMENTAL","A total of 300 patients with intermediate-high risk pulmonary embolism (PE) and no contraindications to ultrasound-assisted catheter-directed thrombolysis will be enrolled. All enrolled patients will undergo thrombolytic therapy using the EkoSonic™ Endovascular System, which provides ultrasound-facilitated catheter-directed delivery of a thrombolytic agent. The total thrombolytic dose and dosing regimen will be determined by the institutional heart team.",[13],"Device: Ultrasound-assisted Catheter-guided Thrombolysis",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Ultrasound-assisted Catheter-guided Thrombolysis","The goal of the ULTRA-PE trial is to investigate the safety and clinical efficacy of ultrasound-assisted catheter-guided thrombolysis in intermediate-high risk patients with pulmonary embolism (PE) in Russia.",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Dmitry Pevzner, MD, D.Sc.","National Medical Research Center for Cardiology named after academician Yevgeniy Chazov of the Ministry of Health of the Russian Federation","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":24,"role":25},"Evgeniy Merkulov, MD, D.Sc.",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":20,"email":33},"Oleg Dorogun, MD","CONTACT","+7 919-764-2159","oleg.dorogun@gmail.com",{"name":35,"role":31,"phone":36,"phoneExt":20,"email":37},"Nikita Grishin, MD","+7 977-579-9185","n.s.grishin@mail.ru",[39],{"facility":24,"status":40,"city":41,"state":20,"zip":20,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Moscow","Russia","RU",{"type":45,"coordinates":46},"Point",[47,48],37.61781,55.75204,{"lat":48,"lon":47},[51,55,58,61,63,65,67,69,71,73,75],{"name":52,"role":31,"phone":53,"phoneExt":20,"email":54},"Ilia Zyuryaev","+7-903-260-49-72","zyuryaev@list.ru",{"name":56,"role":31,"phone":57,"phoneExt":20,"email":37},"Nikita Grishin","+7-977-579-9185",{"name":59,"role":60,"phone":20,"phoneExt":20,"email":20},"Andrey Tereshchenko, MD, PhD","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":20,"phoneExt":20,"email":20},"Goar Arutiunian, MD, PhD",{"name":64,"role":60,"phone":20,"phoneExt":20,"email":20},"Ivan Zharovin, MD",{"name":66,"role":60,"phone":20,"phoneExt":20,"email":20},"Elizaveta Krasnoperova, MD",{"name":68,"role":60,"phone":20,"phoneExt":20,"email":20},"Irina Merkulova, MD",{"name":70,"role":60,"phone":20,"phoneExt":20,"email":20},"Zuliana Bashankaeva, MD",{"name":72,"role":60,"phone":20,"phoneExt":20,"email":20},"Andrey Levshukov, MD",{"name":74,"role":60,"phone":20,"phoneExt":20,"email":20},"Diana Khummedova, MD",{"name":76,"role":60,"phone":20,"phoneExt":20,"email":20},"Nikolay Germanov, MD",{"type":25,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Dmitry Pevzner","Head of the Emergency Cardiology Department","100627773","ultrasound-assisted-catheter-guided-thrombolysis-for-intermediate-high-risk-patients-with-pe-100627773",false,"NCT07452991","ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With PE","ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With Pulmonary Embolism","ULTRA-PE","Inclusion Criteria:\n\n* Adults aged ≥ 18 years at time of enrollment;\n* Ability to provide written informed consent (or legally authorized representative consent where applicable);\n* Objectively confirmed acute pulmonary embolism (PE) by contrast-enhanced computed tomography pulmonary angiography (CTPA) demonstrating intraluminal filling defects in at least one segmental, lobar, or more proximal pulmonary artery;\n* Hemodynamically stable at presentation (i.e., not meeting high-risk PE criteria of sustained hypotension, shock, or need for vasopressor support per ESC 2019 and AHA\u002FACC risk stratification);\n* Evidence of right ventricular (RV) dysfunction on imaging (e.g., RV\u002FLV ratio \\> 1.0 on CTPA or echocardiography);\n* Elevated cardiac biomarkers, including troponin I or T above the upper limit of normal;\n* Intermediate-high risk features defined as the combination of imaging RV dysfunction and positive cardiac biomarkers, consistent with ESC stratification;\n* At least one clinical indicator of elevated early risk such as:\n\n  1. Tachycardia (e.g., HR ≥ 100 bpm),\n  2. Mild systolic blood pressure reduction (e.g., SBP ≤ 110 mmHg but not meeting high-risk thresholds),\n  3. Hypoxemia (SpO₂ \\\u003C 90% on room air).\n\nExclusion Criteria:\n\n* Presence of hemodynamic instability, defined as at least one of the following:\n\n  1. Systolic blood pressure (SBP) \\\u003C 90 mmHg or a drop ≥ 40 mmHg from baseline for \\> 15 minutes not attributable to arrhythmia, hypovolemia, or sepsis,\n  2. Requirement for vasopressors to maintain SBP ≥ 90 mmHg,\n  3. Cardiogenic shock, defined by clinical signs of end-organ hypoperfusion (e.g., altered mental status, oliguria, lactate elevation),\n  4. Need for ECMO or other mechanical circulatory support initiated prior to assessment,\n  5. Cardiac arrest requiring resuscitation.\n* Active major bleeding or conditions with high bleeding risk (e.g., known intracranial pathology predisposed to hemorrhage or associated with ongoing pharmacotherapy);\n* Recent (\\\u003C 3 months) intracranial or intraspinal surgery, major trauma, or stroke;\n* Known central nervous system neoplasm or metastatic cancer with high bleed risk.\n* Administration of systemic thrombolytic agents or catheter-directed thrombolysis prior to registry assessment for the index PE episode;\n* Known hypersensitivity to alteplase, unfractionated heparin (UFH), or any of their excipients.\n* Requirement for intensive care admission for conditions unrelated to the index PE;\n* Duration of symptoms attributable to the index PE \\> 14 days at presentation, as defined in contemporary trial criteria;\n* Known severe thrombocytopenia (e.g., platelet count \\\u003C 100 × 10⁹\u002FL) or coagulopathy precluding safe catheter access;\n* Life expectancy \\\u003C 6 months due to advanced comorbid disease unrelated to acute PE;\n* Pregnancy.","ALL","18 Years",{"count":91,"type":92},300,"ESTIMATED","INTERVENTIONAL",[95],"NA","Pulmonary embolism (PE) is a life-threatening condition and a leading cause of cardiovascular mortality. While systemic thrombolysis is the standard treatment for high-risk PE, its bleeding risk limits use in some patients, highlighting the need for alternative reperfusion strategies such as catheter-directed thrombolysis (CDT). This prospective study will evaluate the safety and efficacy of CDT using the EkoSonic Endovascular System (EKOS; Boston Scientific) in patients with intermediate-high and high-risk PE. The primary outcome is all-cause mortality through 360 days of follow-up, with secondary outcomes including changes in echocardiographic parameters such as the RV\u002FLV diameter ratio.",[98],"Pulmonary Embolism (PE)",[100,17],"Pulmonary embolism","2026-03-13",{"date":103,"type":104},"2026-03-17","ACTUAL",{"date":106,"type":104},"2024-09-10",{"date":108,"type":92},"2030-09-10",{"name":5,"class":6},1]