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Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism

NCT02396758 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2021-07-19

Study results available
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Summary

The objective is to determine the optimum dose of thrombolytic and duration of the ultrasound procedure (together defined as the APT Procedure) as a treatment for acute submassive pulmonary embolism (PE). Symptomatic submassive PE are participants with acute (less than or equal to \[≤\]14 days) PE with normal systemic arterial blood pressure (greater than \[\>\] 90 mmHg) and evidence of RV dysfunction (right ventricular to left ventricular diameter ratio, that is; RV/LV ratio greater than or equal to \[≥\] 0.9). Participants with submassive PE will be randomized to one of four APT treatment groups: ultrasound of 2 and 6 hours (hrs) with r-tPA 2 milligrams (mg)/hr/catheter and ultrasound 4 and 6 hours with r-tPA, 1 mg/hr/catheter. On 08 June 2016, randomization into treatment group 4 (APT/6 hours-r-tPA/2 mg/hr/catheter) was closed following a reported intracranial hemorrhage (ICH) and death in a study participant in this arm.

Conditions

  • Pulmonary Embolism and Thrombosis

Interventions

DEVICE

Ekosonic® Endovascular Device ultrasonic infusion catheter

r-tPA will be administered via EKOS.

BIOLOGICAL

Recombinant tissue plasminogen activator

Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm.

Sponsors & Collaborators

  • EKOS Corporation

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Victor Tapson, MD · Cedar Sinai, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-06-12
Primary Completion
2019-04-30
Completion
2020-01-30

Countries

  • United States
  • United Kingdom

Study Locations

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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 NCT02396758 on ClinicalTrials.gov