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

Study acronym: HI-PEITHO
StatusActive, Not Recruiting
PhasePhase 4
Started2021-08-02
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 61 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-07-27
Study Status, Outcome Measures, Contacts/Locations, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v60
Primary endpoints3 entries, revised
Cardiorespiratory decompensationDecompensation or collapseCollapse PE recurrenceRecurrence PE-related mortalityMortality
Study sitesdetails revised at 1 of 60 sites
2026-06-30
4 amendments v56-v59
4 re-verifications since 2026-04-29, no change to tracked fields
2026-03-24
Study Status, Contacts/Locations v55
Study sites61→60
2026-02-21
Study Status, Contacts/Locations v54
Study sites62→61
2026-01-20
Study Status, Eligibility, Contacts/Locations v53
Study sites63→62
Eligibility criteria+3 characters
[...] 0 mm Hg for at least 15 minutes; respiratory rate > 20 x min^-1 or oxygen saturation on pulse oximetry (SpO2) < 90% (or p [...] al fracture) within the past 3 weeks Platelet count < 100 x 10910^9 x L^-1 Patients who have received a once-daily therapeutic dose [...]
Show 42 earlier versions
2025-10-21
2 amendments v51-v52
2 re-verifications since 2025-09-23, no change to tracked fields
2025-09-05
Study Status v50
Primary completion dateestimated 2025-08→confirmed 2025-07-31
2025-08-21
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v49
Trial statusRecruiting→Active, Not Recruiting
Study sites72→63
2025-07-21
2 amendments v47-v48
2 re-verifications since 2025-06-20, no change to tracked fields
2025-05-13
Study Status, Contacts/Locations v46
Study sitesdetails revised at 7 of 72 sites
2025-04-17
Study Identification, Study Status, Contacts/Locations v45
Study sitesdetails revised at 3 of 72 sites
2025-03-25
Study Status, Contacts/Locations v44
Study sitesdetails revised at 1 of 72 sites
2025-02-18
Study Identification, Study Status, Contacts/Locations v43
Study sitesdetails revised at 3 of 72 sites
2025-01-21
Study Status, Contacts/Locations v42
Study sitesdetails revised at 1 of 72 sites
2024-12-18
Study Identification, Study Status, Contacts/Locations v41
Study sitesdetails revised at 2 of 72 sites
2024-11-21
Study Identification, Study Status, Contacts/Locations v40
Study sitesdetails revised at 4 of 72 sites
2024-10-14
Study Identification, Study Status, Contacts/Locations v39
Study sitesdetails revised at 1 of 72 sites
2024-09-18
Study Status, Contacts/Locations v38
Study sitesdetails revised at 1 of 72 sites
2024-08-19
Study Identification, Study Status, Contacts/Locations v37
Study sitesdetails revised at 2 of 72 sites
2024-07-15
Study Status v36
Re-verified, no change to tracked fields
2024-06-14
Study Status, Contacts/Locations v35
Study sites70→72
2024-05-17
Study Status, Contacts/Locations v34
Study sites64→70
2024-04-12
Study Status, Contacts/Locations v33
Study sites65→64
2024-03-15
Study Status, Contacts/Locations v32
Study sitesdetails revised at 2 of 65 sites
2024-02-12
2 amendments v30-v31
2 re-verifications since 2024-01-16, no change to tracked fields
2023-12-17
Study Status, Study Design v29
Primary completion date2024-07→2025-08
Completion date2025-07→2026-08
Enrollment target406→544
2023-11-15
3 amendments v26-v28
3 re-verifications since 2023-09-15, no change to tracked fields
2023-08-15
Study Status, Contacts/Locations v25
Study sitesdetails revised at 1 of 65 sites
2023-07-14
Study Status, Contacts/Locations v24
Study sitesdetails revised at 2 of 65 sites
2023-06-15
Study Status v23
Re-verified, no change to tracked fields
2023-05-16
Study Status, Contacts/Locations v22
Study sitesdetails revised at 2 of 65 sites
2023-04-15
Study Status, Contacts/Locations v21
Study sitesdetails revised at 4 of 65 sites
2023-03-19
Study Status v20
Re-verified, no change to tracked fields
2023-02-15
Study Status, Contacts/Locations v19
Study sitesdetails revised at 4 of 65 sites
2023-01-16
Study Status, Contacts/Locations v18
Study sitesdetails revised at 6 of 65 sites
2022-12-16
Study Status, Contacts/Locations v17
Study sites64→65
2022-11-15
Study Status, Contacts/Locations v16
Study sitesdetails revised at 4 of 64 sites
2022-10-24
Study Status, Contacts/Locations v15
Study sitesdetails revised at 1 of 64 sites
2022-09-18
Study Status, Arms and Interventions, Contacts/Locations v14
Study sites65→64
2022-08-16
Study Status, Contacts/Locations v13
Study sites63→65
2022-07-19
Study Status, Contacts/Locations v12
Study sites63 entries, revised
OregonUniversitätsklinikum HealthSt. Sciences UniversityPölten
2022-06-20
Study Status, Contacts/Locations v11
Study sites61→63
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.
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