NCT07452991 ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With PE
| NCT ID | NCT07452991 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation |
| Condition | Pulmonary Embolism (PE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-09-10 |
| Primary Completion | 2029-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2024-09-10 with a primary completion date of 2029-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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/LV diameter ratio.
Eligibility Criteria
Inclusion Criteria: * Adults aged ≥ 18 years at time of enrollment; * Ability to provide written informed consent (or legally authorized representative consent where applicable); * 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; * 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/ACC risk stratification); * Evidence of right ventricular (RV) dysfunction on imaging (e.g., RV/LV ratio \> 1.0 on CTPA or echocardiography); * Elevated cardiac biomarkers, including troponin I or T above the upper limit of normal; * Intermediate-high risk features defined as the combination of imaging RV dysfunction and positive cardiac biomarkers, consistent with ESC stratification; * At least one clinical indicator of elevated early risk such as: 1. Tachycardia (e.g., HR ≥ 100 bpm), 2. Mild systolic blood pressure reduction (e.g., SBP ≤ 110 mmHg but not meeting high-risk thresholds), 3. Hypoxemia (SpO₂ \< 90% on room air). Exclusion Criteria: * Presence of hemodynamic instability, defined as at least one of the following: 1. Systolic blood pressure (SBP) \< 90 mmHg or a drop ≥ 40 mmHg from baseline for \> 15 minutes not attributable to arrhythmia, hypovolemia, or sepsis, 2. Requirement for vasopressors to maintain SBP ≥ 90 mmHg, 3. Cardiogenic shock, defined by clinical signs of end-organ hypoperfusion (e.g., altered mental status, oliguria, lactate elevation), 4. Need for ECMO or other mechanical circulatory support initiated prior to assessment, 5. Cardiac arrest requiring resuscitation. * Active major bleeding or conditions with high bleeding risk (e.g., known intracranial pathology predisposed to hemorrhage or associated with ongoing pharmacotherapy); * Recent (\< 3 months) intracranial or intraspinal surgery, major trauma, or stroke; * Known central nervous system neoplasm or metastatic cancer with high bleed risk. * Administration of systemic thrombolytic agents or catheter-directed thrombolysis prior to registry assessment for the index PE episode; * Known hypersensitivity to alteplase, unfractionated heparin (UFH), or any of their excipients. * Requirement for intensive care admission for conditions unrelated to the index PE; * Duration of symptoms attributable to the index PE \> 14 days at presentation, as defined in contemporary trial criteria; * Known severe thrombocytopenia (e.g., platelet count \< 100 × 10⁹/L) or coagulopathy precluding safe catheter access; * Life expectancy \< 6 months due to advanced comorbid disease unrelated to acute PE; * Pregnancy.
Contact & Investigator
Dmitry Pevzner, MD, D.Sc.
PRINCIPAL INVESTIGATOR
National Medical Research Center for Cardiology named after academician Yevgeniy Chazov of the Ministry of Health of the Russian Federation
Frequently Asked Questions
Who can join the NCT07452991 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Embolism (PE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07452991 currently recruiting?
Yes, NCT07452991 is actively recruiting participants. Contact the research team at oleg.dorogun@gmail.com for enrollment information.
Where is the NCT07452991 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT07452991 clinical trial?
NCT07452991 is sponsored by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation. The principal investigator is Dmitry Pevzner, MD, D.Sc. at National Medical Research Center for Cardiology named after academician Yevgeniy Chazov of the Ministry of Health of the Russian Federation. The trial plans to enroll 300 participants.