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NCT05597891 · ClinicalTrials.gov registry record · NA
Endovascular Engineering ENGULF Study
A NA study of Pulmonary Embolism, sponsored by Endovascular Engineering.
- Recruiting
- Registry status
- NA
- Development phase
- 181
- Enrollment target
- 19
- Study locations
NCT05597891: Recruiting NA study of Pulmonary Embolism, sponsored by Endovascular Engineering.
NCT05597891 is a NA study of Pulmonary Embolism that is actively recruiting participants, run by Endovascular Engineering. The registered enrollment target is 181 participants, below the 3,055-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (94% lower). The trial reports 19 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05597891, a NA study of Pulmonary Embolism, is actively recruiting participants, sponsored by Endovascular Engineering.
- RECRUITING
- Registry status
- NA
- Development phase
- 181 participants
- Enrollment target
- 19
- Study locations
Study Summary
Evaluation of initial safety and clinical feasibility of the Hēlo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE).
Primary Outcome
Composite device-related Major Adverse Event (MAE) rate, defined as any of the following events within 48 hours (+/- 24 hours) of the procedure: * Death * Life-threatening, disabling or major bleeding as defined by VARC-2 * Serious adverse events, including, clinical deterioration, pulmonary vascular injury, and cardiac injury
Conditions Studied
Interventions
- DEVICE Hēlo PE Thombectomy System
Study Locations (19)
California
- Huntington Hospital - Pasadena
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
- Torrance Memorial Medical Center - Torrance
Florida
- Delray Medical Center - Delray Beach
- Baptist Health Research Institute - Jacksonville
- HCA Florida Memorial Hospital - Jacksonville
Texas
- Austin Heart - Austin
- Baylor Scott & White Research Institute - Dallas
- UT Health - Houston
Georgia
- Piedmont Heart - Atlanta
- Northside Hospital - Atlanta
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Brigham and Women's Hospital - Boston
Tennessee
- Wellmont Cardiology Services / Ballad Health - Kingsport
- Tennova Healthcare - Turkey Creek Medical Center - Knoxville
Indiana
- Indiana University - Indianapolis
Ohio
- TriHealth Hatton Research Institute - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2023-01-12 |
| Est. Completion | 2025-09-30 |
| Phase | NA |
What NCT05597891 shows while recruiting
NCT05597891 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, below the 3,055-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Pulmonary Embolism appearing as the primary indexed condition, and to 1 intervention - of which Hēlo PE Thombectomy System is the first listed.
NCT05597891 lists 19 locations in 10 states (California, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT05597891 about?
NCT05597891 is a clinical study titled "Endovascular Engineering ENGULF Study". Evaluation of initial safety and clinical feasibility of the Hēlo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE).
What is the current status of trial NCT05597891?
This trial is currently recruiting. It is a NA study. The enrollment target is 181 participants. The study started on 2023-01-12. Estimated completion is 2025-09-30.
What conditions does trial NCT05597891 study?
This clinical trial studies the following conditions: Pulmonary Embolism.
What interventions are being tested in trial NCT05597891?
The interventions under investigation include: Hēlo PE Thombectomy System (DEVICE).
Who is sponsoring clinical trial NCT05597891?
This trial is sponsored by Endovascular Engineering, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05597891 being conducted?
This trial has 19 study locations across California, Florida, Georgia, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Embolism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05597891's enrollment target sits among peer trials
181 27th of 48 higher than 22 of 48 other Pulmonary Embolism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Embolism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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