Thrombolysis Endovascular Treatment of Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— STEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966079
• Other study ID #: BeijingTCGH
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: November 2020
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pulmonary Embolism
• Embolism
• Pulmonary Embolism

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tsinghua Chang Gung Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline and 30days after baseline
Secondary	Rate of death		30days
Secondary	Rate of major Bleeding		30days
Secondary	Pulmonary embolism recurrence		30days