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Peripheral Systemic Thrombolysis Versus Catheter Directed Thrombolysis for Submassive PE

NCT03581877 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-10-03

No results posted yet for this study

Summary

To determine whether peripheral low dose systemic thrombolysis (PLST) is non-inferior to catheter directed acoustic pulse thrombolysis (ACDT) in improving RV function and reducing pulmonary artery pressures in submassive pulmonary embolism (PE)

Conditions

Interventions

DRUG

Alteplase

As stated before, low dose r-tpa will be administered through a peripheral vein for PLST.

DEVICE

EKOS

As stated before, the EKos device will be used for ultrasound assisted catheter directed thrombolysis or ACDT, same dose t-tpa will administered through the pulmonary catheter. It will be given at a fixed dose over 24 hours.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • Azhar Supariwala, MD · Southside Northwell Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2023-03-19
Completion
2025-03-19
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03581877 on ClinicalTrials.gov