Skip to main content
OpenTrials
Completed

NCT Number: NCT03966079

Thrombolysis Endovascular Treatment of Pulmonary Embolism

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant tissue plasminogen activator

Drug

Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter

Other names: rtPA

Primary outcomes

  1. Change of RV to LV Diameter Ratio

    Time frame: baseline and 30days after baseline

    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

Secondary outcomes

  1. Rate of death

    Time frame: 30days

  2. Rate of major Bleeding

    Time frame: 30days

  3. Pulmonary embolism recurrence

    Time frame: 30days

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study title

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

Acronym: STEP

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 29, 2019
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.