Thrombolysis Endovascular Treatment of Pulmonary Embolism

Study Overview
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Brief Summary
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To assess the efficacy and safety of endovascular thrombolysis of pulmonary embolism with right ventricular dysfunction with single-dose rtPA

Detailed Description
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The patients with right ventricular dysfunction who are diagnosed by CT pulmonary angiography will receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the in this study. The Change of RV to LV Diameter Ratio,Rate of death,rate of major bleeding,pulmonary embolism recurrence at 1month will be reviewed to assess the efficacy and safety.

Official Title
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Single-dose rtPA Thrombolysis Endovascular Treatment of Pulmonary Embolism With Right Ventricular Dysfunction:a Pilot Study

Conditions
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Pulmonary Embolism, Acute Pulmonary Embolism

Intervention / Treatment
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* Drug: recombinant tissue plasminogen activator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CT evidence of proximal PE Age ≥ 18 years Pulmonary embolism symptom duration ≤14 days Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) OR Submassive PE (RV diameter-to-LV diameter ≥ 0.9 on contrast-enhanced chest CT) Exclusion Criteria: Age <18 years PE symptom duration >14 days Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year Recent (within one month) or active bleeding from a major organ Pregnancy Chronic pulmonary hypertension or severe chronic obstructive pulmonary disease Administration of thrombolytic agents within the previous 3 days Life expectancy < 30 days Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated Inability to follow protocol requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter | Drug: recombinant tissue plasminogen activator<br>* Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter<br>* Other names: rtPA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of RV to LV Diameter Ratio | Determine whether single-dose rtpa catheter-directed thrombolysis decrease the ratio of right ventricular (RV)-to-left ventricular (LV) diameter within 1month in patients with right ventricular dysfunction | baseline and 30days after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of death |  | 30days | 
| Rate of major Bleeding |  | 30days | 
| Pulmonary embolism recurrence |  | 30days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Pulmonary Embolism