Thrombolysis Endovascular Treatment of Pulmonary Embolism (STEP)

November 26, 2020 updated by: Beijing Tsinghua Chang Gung Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 102218
        • Beijing Tsinghua Chang Gung Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter
Drug: recombinant tissue plasminogen activator
Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter
Other Names:
  • rtPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 30days after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of death
Time Frame: 30days
30days
Rate of major Bleeding
Time Frame: 30days
30days
Pulmonary embolism recurrence
Time Frame: 30days
30days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tsinghua Chang Gung Hospital

Investigators

  • Study Director: Wu weiwei, doctor, director of department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

May 27, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 26, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeijingTCGH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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