Thrombolysis Endovascular Treatment of Pulmonary Embolism

NCT03966079 | Completed Phase 3

• 1 other identifier: BeijingTCGH
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Embolism; Acute Pulmonary Embolism

Keywords

Acute Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of death

  30days

• Rate of major Bleeding

  30days

• Pulmonary embolism recurrence

  30days

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Drug: recombinant tissue plasminogen activator

Interventions

recombinant tissue plasminogen activator DRUG

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

Also known as: rtPA

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

Location

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Wu weiwei, doctor

  Director of department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Single Group Assignment

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 29, 2019
• Study Start: January 1, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

CN (1)