Ultrasound-assisted, Catheter-directed Thrombolysis for Acute Intermediate-high-risk Pulmonary Embolism
NCT ID: NCT06143969
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
180 participants
OBSERVATIONAL
2022-11-28
2027-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In the latest 2019 European Society of Cardiology (ESC) Guidelines patients diagnosed with PE are stratified into different risk groups according to clinical history, hemodynamic status, cardiac biomarkers and imaging assessment of right ventricular (RV) function.
Traditionally, reperfusion therapy with systemic thrombolysis is the treatment of choice in high-risk PE, defined by sustained systemic arterial hypotension, cardiogenic shock, or the need for cardiopulmonary resuscitation.
In the setting of intermediate-risk PE,characterized by the absence of hemodynamic instability but elevated cardiac biomarkers or RV disfunction at imaging, the ESC guidelines recognize two sub-categories: intermediate-high if both signs are identified or intermediate-low, if only one of them is present.Approximately one quarter of hemodynamically stable patients with PE are at intermediate-risk, with mortality rates ranging from 3% to 15% if imaging or biomarker evidence of RV dilatation or dysfunction is present.4,5 In this subset of patients the optimal treatment strategy is still an object of debate.
A combination of ultrasound- based fragmentation of the thrombus and catheter-directed thrombolysis, requiring a reduced dose of the thrombolytic agent, has been developed. This localized therapy is currently recommended by the ESC guidelines (class IIa, LOE C) for patients with high-risk PE and contraindications for systemic thrombolysis or intermediate-high-risk PE and hemodynamic deterioration on anticoagulation treatment.
The investigators propose an observational cohort study aimed at assessing the impact on short and long-term outcome of ultrasound-assisted, catheter-directed thrombolysis using EKOSTM in a real-word population of subjects with acute intermediate-high risk PE treated in multiple Italian centers.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EkoSonicTM Endovascular System (EKOSTM, Boston Scientific)
Patients hospitalized with acute intermediate-high risk PE treated with ultrasound-assisted, catheter-directed thrombolysis using EKOSTM.
ultrasound-assisted, catheter-directed thrombolysis
After 10 hours of alteplase infusion and EKOSTM ultrasound, the therapy is stopped, the EKOSTM catheter is removed, and the puncture site (internal jugular vein or femoral vein) has to be compressed.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ultrasound-assisted, catheter-directed thrombolysis
After 10 hours of alteplase infusion and EKOSTM ultrasound, the therapy is stopped, the EKOSTM catheter is removed, and the puncture site (internal jugular vein or femoral vein) has to be compressed.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Symptoms onset within previous 14 days associated or not with deep venous thrombosis
* Confirmation of the PE by contrast-enhanced computed tomography of the chest with embolus located in at least one main or proximal lower lobe pulmonary artery
* Echocardiographic parameters of RV disfunction
* Patients with high-risk PE or hemodynamic deterioration on anticoagulation, who have absolute contraindications (high bleeding risk) to systemic thrombolysis and symptoms onset during the last 14 days. Patients with surgery-related embolic complications are also included (within 48 hours).
Exclusion Criteria
* Patients unable to give informed consent
* Pregnancy
* Patients received fibrinolytic drugs in the preceding 4 days
* Bleeding diathesis
* Known bleeding disorder
* Low platelet count (\< 100.000/uL
* Gastrointestinal bleeding in the preceding 3 month
* Any ongoing known presence of malignant neoplasia months
* Advanced chronic kidney disease (defined as 11.000/uL)
* Gastrointestinal bleeding in the preceding 3 month
* Any ongoing known presence of malignant neoplasia at admission with survival rate \< 6
* Advanced chronic kidney disease (defined as eGFR \< 30 ml/min or on dialysis)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Niguarda Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ASST GOM Niguarda
Milan, Italia, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
652-28112022
Identifier Type: -
Identifier Source: org_study_id