MedTrace Logo

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

NCT04790370 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2026-05-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Anticoagulation with heparin

Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH)

DEVICE

EkoSonicTM Endovascular System

EkoSonicTM Endovascular System \[ultrasound-facilitated catheter-directed delivery of thrombolytic: 2 mg bolus/catheter + 1 mg/hour/catheter for 7 hours (total of 9 or 18 mg\]

Sponsors & Collaborators

  • National PERT Consortium, Inc.

    collaborator UNKNOWN

  • University Medical Center Mainz

    collaborator OTHER

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Stavros Konstantinides, MD · University Medical Center Mainz, Mainz, Germany

  • Kenneth Rosenfield, MD · Massachusetts General Hospital, Boston, Massachusetts, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-08-02
Primary Completion
2025-07-31
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States
  • Austria
  • France
  • Germany
  • Ireland
  • Netherlands
  • Poland
  • Switzerland
  • United Kingdom

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 NCT04790370 on ClinicalTrials.gov