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CompletedNCT03966079STEPUpdated Nov 30, 2020

Thrombolysis Endovascular Treatment of Pulmonary Embolism

A Phase 3 interventional study of recombinant tissue plasminogen activator in Pulmonary Embolism and Acute Pulmonary Embolism, sponsored by Beijing Tsinghua Chang Gung Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-30.

Sponsored by Beijing Tsinghua Chang Gung Hospital · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Jan 2017, registered May 2019).
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Pulmonary Embolism
  • Acute Pulmonary Embolism

Keywords

  • Acute Pulmonary Embolism
03

In context

Pulmonary Embolism

739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.

This study's enrollment of 50 is below the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 96 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Intervention arm

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

    Drug: recombinant tissue plasminogen activator

Interventions

  • Drugrecombinant tissue plasminogen activator

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

    Also known as: rtPA

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline and 30days after baseline

Secondary outcomes

  1. Rate of death

    Time frame: 30days

  2. Rate of major Bleeding

    Time frame: 30days

  3. Pulmonary embolism recurrence

    Time frame: 30days

07

Study locations

1 site
  • Beijing Tsinghua Chang Gung Hospital
    Beijing, Beijing 102218, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03966079
Lead sponsor
Beijing Tsinghua Chang Gung Hospital
Responsible party
Sponsor
First posted
May 29, 2019
Start date
Jan 1, 2017
Primary completion
Jan 31, 2020
Completion
Jan 31, 2020
Last update
Nov 30, 2020

Study contacts

Wu weiwei, doctor
study director · Director of department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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