Ultrasound-assisted, Catheter-directed Thrombolysis for Acute Intermediate-high-risk Pulmonary Embolism
- Conditions
- Pulmonary Embolism
- Interventions
- Procedure: ultrasound-assisted, catheter-directed thrombolysis
- Registration Number
- NCT06143969
- Lead Sponsor
- Niguarda Hospital
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description EkoSonicTM Endovascular System (EKOSTM, Boston Scientific) ultrasound-assisted, catheter-directed thrombolysis Patients hospitalized with acute intermediate-high risk PE treated with ultrasound-assisted, catheter-directed thrombolysis using EKOSTM.
- Primary Outcome Measures
Name Time Method development of pulmonary hypertension 6 months from treatment number of cases
- Secondary Outcome Measures
Name Time Method PE within 6 months from treatment PE recurrence (number of events)
stroke within 6 months from treatment number of events
Re-hospitalization within 6 months from treatment Re-hospitalization (number of events)
death within 6 months from treatment death from any cause (cancer, sepsis, respiratory failure, other) number of events
changes of echocardiographic parameters 24 hours after the treatment and at 3-6 months follow-up * 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)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) 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)
Trial Locations
- Locations (1)
ASST GOM Niguarda
🇮🇹Milano, Italia, Italy