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NCT04790370 · ClinicalTrials.gov registry record · Phase 4
Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism
A Phase 4 study of Pulmonary Embolism, sponsored by Boston Scientific Corporation.
- Active
- Registry status
- Phase 4
- Development phase
- 544
- Enrollment target
- 20
- Study locations
NCT04790370 is a Phase 4 study of Pulmonary Embolism that is active but no longer recruiting, run by Boston Scientific Corporation. The registered enrollment target is 544 participants, below the 3,047-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT04790370, a Phase 4 study of Pulmonary Embolism, is active but no longer recruiting, sponsored by Boston Scientific Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 544 participants
- Enrollment target
- 20
- Study locations
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 Studied
Interventions
- DRUG Anticoagulation with heparin
- DEVICE EkoSonicTM Endovascular System
Study Locations (20)
Georgia
- Piedmont Hospital - Atlanta
- Emory University Hospital - Atlanta
- Augusta University - Augusta
New York
- Mount Sinai Medical Center - New York
- Columbia University Medical Center - New York
- Lenox Hill Hospital - New York
Michigan
- University of Michigan Hospitals - Ann Arbor
- Henry Ford Hospital - Detroit
New Jersey
- Cooper Hospital - University Medical Center - Camden
- Newark Beth Israel Medical Center - Newark
Alabama
- University of Alabama at Birmingham - Birmingham
California
- Cedars - Sinai Medical Center - Los Angeles
Delaware
- Christiana Hospital - Newark
Indiana
- Methodist Hospitals - Merrillville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 544 participants |
| Start Date | 2021-08-02 |
| Est. Completion | 2026-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04790370
The ClinicalTrials.gov registry entry for NCT04790370 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 544 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,047-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (82% lower). The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pulmonary Embolism appearing as the primary indexed condition, and to 2 interventions - of which Anticoagulation with heparin is the first listed.
NCT04790370 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Georgia, New York, Michigan.
Frequently Asked Questions
What is clinical trial NCT04790370 about?
NCT04790370 is a clinical study titled "Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism". 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 thin...
What is the current status of trial NCT04790370?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 544 participants. The study started on 2021-08-02. Estimated completion is 2026-08.
What conditions does trial NCT04790370 study?
This clinical trial studies the following conditions: Pulmonary Embolism.
What interventions are being tested in trial NCT04790370?
The interventions under investigation include: Anticoagulation with heparin (DRUG), EkoSonicTM Endovascular System (DEVICE).
Who is sponsoring clinical trial NCT04790370?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04790370 being conducted?
This trial has 20 study locations across Alabama, California, Delaware, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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