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Standard vs. Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism

NCT02758574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2021-09-05

No results posted yet for this study

Summary

The study will compare standard catheter directed thrombolysis to ultrasound accelerated thrombolysis for the treatment of acute submassive pulmonary embolism (PE). The study population will include patients eligible for catheter directed thrombolysis (CDT) for submassive PE. Subjects will be randomized to, either, standard catheter-directed thrombolysis or ultrasound-accelerated thrombolysis (USAT).

Conditions

Interventions

PROCEDURE

CDT without ultrasound acceleration

A pulmonary arteriogram will be performed. Upon confirmation of the pulmonary embolus a standard infusion catheter will be placed within the clot. The catheter will be used for infusion of thrombolytics to treat/dissolve the pulmonary embolus.

PROCEDURE

CDT with ultrasound acceleration

A pulmonary arteriogram will be performed. Upon confirmation of the pulmonary embolus an infusion catheter that incorporates an ultrasound emitting wire will be placed within the clot. The catheter will be used for infusion of thrombolytics to treat/dissolve the pulmonary embolus. The wire will be connected to an ultrasound generating device.

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Efthymios Avgerinos, M.D. · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • United States

Study Locations

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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 NCT02758574 on ClinicalTrials.gov