Pulmonary EmbolismUSAT IH-PENCT06143969
Ultrasound-assisted, Catheter-directed Thrombolysis for Acute Intermediate-high-risk Pulmonary Embolism
An observational study of Pulmonary Embolism, run by Niguarda Hospital at 1 site in Italy.
Trial summary
The purpose of this retrospective and prospective multicenter study is to evaluate the incidence of pulmonary hypertension (PH) within 6 months from ultrasound-assisted, Catheter-directed Thrombolysis for acute intermediate- high-risk Pulmonary Embolism Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- ultrasound-assisted, catheter-directed thrombolysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 28 Nov 2022to 31 Mar 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients hospitalized with intermediate high-risk pulmonary embolism
Who may be able to join
- Patients admitted with acute intermediate-high risk PE, defined according to ESC guidelines
- 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).
Who cannot join
- Age < 18 years old
- Patients unable to give informed consent
- Pregnancy
- Patients received fibrinolytic drugs in the preceding 4 days
- Bleeding diathesis
- Known bleeding disorder
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST GOM Niguarda
Milan, Italia, 20162
Alice Sacco, MD, 0039026444 ext. 2565, alice.sacco@ospedaleniguarda.it
Dario Brunelli, PhD, 0039026444 ext. 6516, dario.brunelli@ospedaleniguarda.it
About this study
Official title: Ultrasound-assisted, Catheter-directed Thrombolysis for Acute Intermediate-high-risk Pulmonary Embolism (USAT IH-PE): Impact on Short- and Long-term Outcome, a Multi-center Experience. An Observational Retrospective and Prospective Multi-center Study
The purpose of this retrospective and prospective multicenter study is to evaluate the incidence of pulmonary hypertension (PH) within 6 months from ultrasound-assisted, Catheter-directed Thrombolysis for acute intermediate- high-risk Pulmonary Embolism
Read the detailed description
Acute pulmonary embolism (PE) is a potentially life-threatening disease spanning a wide spectrum of clinical outcomes. PE is the third most common cardiovascular disorder in Europe and USA and causes an estimated 150,000 to 200,000 deaths.
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
- Pulmonary Embolism
- Being tested
- ultrasound-assisted, catheter-directed thrombolysis
- Keywords
- pulmonary embolism, intermediate high-risk, Ultrasound-assisted, Catheter-directed Thrombolysis
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-assisted, catheter-directed thrombolysisProcedure or surgery
Also called EkoSonicTM Endovascular System (EKOSTM, Boston Scientific)
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.
| Study group | Role | What they receive |
|---|---|---|
| EkoSonicTM Endovascular System (EKOSTM, Boston Scientific) | Patients hospitalized with acute intermediate-high risk PE treated with ultrasound-assisted, catheter-directed thrombolysis using EKOSTM. Receives: Procedure: ultrasound-assisted, catheter-directed thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of pulmonary hypertension
number of cases
Measured: 6 months from treatment
Secondary outcomes (7)
changes of echocardiographic parameters
- tricuspid annular plane excursion (TAPSE) (mm)
- right ventricle/left ventricle ratio (RV/LV) ratio (decimal)
- acceleration time (ACT) time (seconds)
- fractional area change (FAC)
- S' TDI RV (cm/sec)
- pulmonary artery systolic pressure (PAPs) (mmHg)
- tricuspid regurgitant velocity (TRV) (m/s)
Measured: 24 hours after the treatment and at 3-6 months follow-up
death
death during hospital stay (number of events)
Measured: within 6 months from treatment
death
death from any cause (cancer, sepsis, respiratory failure, other) number of events
Measured: within 6 months from treatment
PE
PE recurrence (number of events)
Measured: within 6 months from treatment
Major bleeding within 6 months from treatment (Bleeding Academic Research Consortium-major bleedings defined as BARC 3-5 events; clinically relevant non major bleedings defined as BARC 2 event) (number of events)
Bleeding Academic Research Consortium-major bleedings defined as BARC 3-5 events; clinically relevant non major bleedings defined as BARC 2 event (number of events)
Measured: within 6 months from treatment
stroke
number of events
Measured: within 6 months from treatment
Re-hospitalization
Re-hospitalization (number of events)
Measured: within 6 months from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start28 Nov 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143969
- Sponsor's protocol ID
- 652-28112022
- Acronym
- USAT IH-PE
- Status last verified
- Apr 2026
- First submitted
- 15 Nov 2023
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-assisted, Catheter-directed Thrombolysis for Acute Intermediate-high-risk Pulmonary Embolism (USAT IH-PE): Impact on Short- and Long-term Outcome, a Multi-center Experience. An Observational Retrospective and Prospective Multi-center Study
- ClinicalTrials.gov ID
- NCT06143969
- Acronym / sponsor ID
- USAT IH-PE / 652-28112022
- Conditions
- Pulmonary Embolism
- Keywords
- pulmonary embolism, intermediate high-risk, Ultrasound-assisted, Catheter-directed Thrombolysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this retrospective and prospective multicenter study is to evaluate the incidence of pulmonary hypertension (PH) within 6 months from ultrasound-assisted, Catheter-directed Thrombolysis for acute intermediate- high-risk Pulmonary Embolism
Detailed description
Acute pulmonary embolism (PE) is a potentially life-threatening disease spanning a wide spectrum of clinical outcomes. PE is the third most common cardiovascular disorder in Europe and USA and causes an estimated 150,000 to 200,000 deaths.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EkoSonicTM Endovascular System (EKOSTM, Boston Scientific) | – | Procedure: ultrasound-assisted, catheter-directed thrombolysisPatients hospitalized with acute intermediate-high risk PE treated with ultrasound-assisted, catheter-directed thrombolysis using EKOSTM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized with intermediate high-risk pulmonary embolism
Key inclusion criteria (5 listed)
- Patients admitted with acute intermediate-high risk PE, defined according to ESC guidelines
- 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).
Key exclusion criteria (13 listed)
- Age < 18 years old
- Patients unable to give informed consent
- Pregnancy
- Patients received fibrinolytic drugs in the preceding 4 days
- Bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound-assisted, catheter-directed thrombolysisAlso: EkoSonicTM Endovascular System (EKOSTM, Boston Scientific)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. | Procedure or surgery | EkoSonicTM Endovascular System (EKOSTM, Boston Scientific) |
Primary outcome
development of pulmonary hypertension
Time frame: 6 months from treatment
number of cases
7 secondary outcomes
changes of echocardiographic parameters
Time frame: 24 hours after the treatment and at 3-6 months follow-up
death
Time frame: within 6 months from treatment
death
Time frame: within 6 months from treatment
PE
Time frame: within 6 months from treatment
Major bleeding within 6 months from treatment (Bleeding Academic Research Consortium-major bleedings defined as BARC 3-5 events; clinically relevant non major bleedings defined as BARC 2 event) (number of events)
Time frame: within 6 months from treatment
stroke
Time frame: within 6 months from treatment
Re-hospitalization
Time frame: within 6 months from treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Sacco, MD (0039026444 ext. 2565, alice.sacco@ospedaleniguarda.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of pulmonary hypertension (time frame: 6 months from treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.