Thrombolysis Endovascular Treatment of Pulmonary Embolism

Phase 3

Completed

• Conditions: Acute Pulmonary Embolism; Pulmonary Embolism
• Interventions: Drug: recombinant tissue plasminogen activator

• Registration Number: NCT03966079
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-29
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change of RV to LV Diameter Ratio	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 Outcome Measures

Name	Time	Method
Rate of major Bleeding	30days
Pulmonary embolism recurrence	30days
Rate of death	30days

Trial Locations

Locations (1)

Beijing Tsinghua Chang Gung Hospital; 🇨🇳 Beijing, Beijing, China