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Active, not recruiting Phase 4 Interventional

Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism

ClinicalTrials.gov ID: NCT04790370

Public ClinicalTrials.gov record NCT04790370. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 5:10 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Trial of Ultrasound-facilitated, Catheter-directed, Thrombolysis Versus Anticoagulation for Acute Intermediate-high Risk Pulmonary Embolism: The Higher-risk Pulmonary Embolism Thrombolysis Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE. Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.

Study identification

NCT ID
NCT04790370
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 4
Lead sponsor
Boston Scientific Corporation
Industry
Enrollment
544 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2, 2021 (Actual)
Primary completion
Jul 31, 2025 (Actual)
Completion
Aug 2026 (Estimated)
Last update posted
Jul 1, 2026

2021 – 2026

United States locations

U.S. sites
28
U.S. states
19
U.S. cities
25
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 —
Cedars - Sinai Medical Center Los Angeles California 90048 —
Christiana Hospital Newark Delaware 19718 —
Piedmont Hospital Atlanta Georgia 30309 —
Emory University Hospital Atlanta Georgia 30322 —
Augusta University Augusta Georgia 30904 —
Methodist Hospitals Merrillville Indiana 46410 —
Baptist Health East Louisville Lousville Kentucky 40207 —
University of Maryland School of Medicine Baltimore Maryland 21201 —
Massachusetts General Hospital Boston Massachusetts 02114 —
University of Michigan Hospitals Ann Arbor Michigan 48109 —
Henry Ford Hospital Detroit Michigan 48202 —
North Mississippi Medical Center Tupelo Mississippi 38801 —
Nebraska Methodist Hospital Omaha Nebraska 68114 —
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756 —
Newark Beth Israel Medical Center Newark New Jersey 07112 —
Mount Sinai Medical Center New York New York 10029 —
Columbia University Medical Center New York New York 10032 —
Lenox Hill Hospital New York New York 10075 —
University Hospitals of Cleveland Cleveland Ohio 44106 —
Kettering Health Kettering Ohio 45429 —
Wellmont Holston Valley Medical Center Kingsport Tennessee 37660 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
Seton Medical Center Austin Texas 78705 —
Houston Methodist Sugarland Hospital Houston Texas 77479 —
The Heart Hospital Baylor Plano Plano Texas 75093 —
University of Virginia Medical Center Charlottesville Virginia 22908 —
University of Wisconsin Hospitals Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 32 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04790370, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 1, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04790370 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →