Thrombolysis Endovascular Treatment of Pulmonary Embolism

• Status: Completed
• Trial end date: 2020-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital
• Treatments: Plasminogen; Tissue Plasminogen Activator

Criteria

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