Back to resultsThrombolysis Endovascular Treatment of Pulmonary Embolism (STEP)
Primary Purpose
Pulmonary Embolism, Acute Pulmonary Embolism
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
recombinant tissue plasminogen activator
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Embolism focused on measuring Acute Pulmonary Embolism
Eligibility 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
Sites / Locations
- Beijing Tsinghua Chang Gung Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Rate of death
Rate of major Bleeding
Pulmonary embolism recurrence
Full Information
NCT ID
NCT03966079
First Posted
May 20, 2019
Last Updated
November 26, 2020
Sponsor
Beijing Tsinghua Chang Gung Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03966079
Brief Title
Thrombolysis Endovascular Treatment of Pulmonary Embolism
Acronym
STEP
Official Title
Single-dose rtPA Thrombolysis Endovascular Treatment of Pulmonary Embolism With Right Ventricular Dysfunction:a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tsinghua Chang Gung Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the efficacy and safety of endovascular thrombolysis of pulmonary embolism with right ventricular dysfunction with single-dose rtPA
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Acute Pulmonary Embolism
Keywords
Acute Pulmonary Embolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Prospective Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter
Intervention Type
Drug
Intervention Name(s)
recombinant tissue plasminogen activator
Other Intervention Name(s)
rtPA
Intervention Description
Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter
Primary Outcome Measure Information:
Title
Change of RV to LV Diameter Ratio
Description
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 Outcome Measure Information:
Title
Rate of death
Time Frame
30days
Title
Rate of major Bleeding
Time Frame
30days
Title
Pulmonary embolism recurrence
Time Frame
30days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu weiwei, doctor
Organizational Affiliation
Director of department
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Tsinghua Chang Gung Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102218
Country
China
12. IPD Sharing Statement
Learn more about this trial
Thrombolysis Endovascular Treatment of Pulmonary Embolism
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