💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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