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New treatment option for Pulmonary Embolism (PE)
Official title ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With PE
ClinicalTrials.gov ID: NCT07452991
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Hemodynamically stable at presentation (i.e., not meeting high-risk PE criteria of sustained hypotension, shock, or need for vasopressor support per...
- Evidence of right ventricular (RV) dysfunction on imaging (e.g., RV/LV ratio \> 1.0 on CTPA or echocardiography);
You likely can't join if
- Presence of hemodynamic instability, defined as at least one of the following:
- Systolic blood pressure (SBP) \ 15 minutes not attributable to arrhythmia, hypovolemia, or sepsis,
- Requirement for vasopressors to maintain SBP ≥ 90 mmHg,
- Cardiogenic shock, defined by clinical signs of end-organ hypoperfusion (e.g., altered mental status, oliguria, lactate elevation),
- Need for ECMO or other mechanical circulatory support initiated prior to assessment,
- Cardiac arrest requiring resuscitation.
See the full eligibility 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...
- 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:
- Tachycardia (e.g., HR ≥ 100 bpm),
- Mild systolic blood pressure reduction (e.g., SBP ≤ 110 mmHg but not meeting high-risk thresholds),
- Hypoxemia (SpO₂ \< 90% on room air).
- Presence of hemodynamic instability, defined as at least one of the following:
- Systolic blood pressure (SBP) \ 15 minutes not attributable to arrhythmia, hypovolemia, or sepsis,
- Requirement for vasopressors to maintain SBP ≥ 90 mmHg,
- Cardiogenic shock, defined by clinical signs of end-organ hypoperfusion (e.g., altered mental status, oliguria, lactate elevation),
- Need for ECMO or other mechanical circulatory support initiated prior to assessment,
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.