Thrombolysis Endovascular Treatment of Pulmonary Embolism (STEP)

Beijing Tsinghua Chang Gung Hospital

Status and phase

Completed

Phase 3

Conditions

Pulmonary Embolism

Acute Pulmonary Embolism

Treatments

Drug: recombinant tissue plasminogen activator

Study type

Interventional

Funder types

Other

Identifiers

NCT03966079

BeijingTCGH

Details and patient eligibility

About

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

Full description

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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