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Thrombolysis Endovascular Treatment of Pulmonary Embolism

NCT ID: NCT03966079

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pulmonary Embolism Acute Pulmonary Embolism

Keywords

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Acute Pulmonary Embolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective Single Group Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention arm

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

Group Type EXPERIMENTAL

recombinant tissue plasminogen activator

Intervention Type DRUG

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

Interventions

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recombinant tissue plasminogen activator

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

Intervention Type DRUG

Other Intervention Names

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rtPA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wu weiwei, doctor

Role: STUDY_DIRECTOR

Director of department

Locations

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Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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BeijingTCGH

Identifier Type: -

Identifier Source: org_study_id