Clinical Trial

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

Study acronym: HI-PEITHO

Active, Not Recruiting Phase 4

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.

Protocol Amendment History 59 amendments

This ClinicalTrials.gov record has been amended 59 times since 2021-03-05; most recent amendment 2026-06-30.

Status change: Recruiting → Active, Not Recruiting 2025-08-21

Status change: Not Yet Recruiting → Recruiting 2021-07-15

Trial Details

NCT Number	NCT04790370
Lead Sponsor	Boston Scientific Corporation Collaborators: National PERT Consortium, Inc., University Medical Center Mainz
Conditions	Pulmonary Embolism
Enrollment	544 participants
Start Date	2021-08-02
Primary Completion	2025-07-31 (estimated)
Study Completion	2026-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-01