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NCT04248868 · ClinicalTrials.gov registry record · Phase 3
tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden
A Phase 3 study of Pulmonary Embolism, sponsored by Thrombolex.
- Completed
- Registry status
- Phase 3
- Development phase
- 109
- Enrollment target
- 19
- Study locations
NCT04248868: Completed Phase 3 study of Pulmonary Embolism, sponsored by Thrombolex.
NCT04248868 is a Phase 3 study of Pulmonary Embolism that has completed, run by Thrombolex. The registered enrollment target is 109 participants, below the 3,056-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (96% lower). The trial reports 19 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04248868, a Phase 3 study of Pulmonary Embolism, has completed, sponsored by Thrombolex.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 109 participants
- Enrollment target
- 19
- Study locations
Study Summary
To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism.
Primary Outcome
Observe RV/LV diameter ratio difference between baseline and 48 hours after the completion of r-tPA treatment as measured by contrast enhanced chest CT (CTA).
Conditions Studied
Interventions
- DRUG r-tPA
- DEVICE The Bashir™ Endovascular Catheter
Study Locations (19)
Pennsylvania
- UPMC Hamot - Erie
- Temple University Hospital - Philadelphia
- UPMC Heart and Vascular Institute - Pittsburgh
Florida
- Miami Cardiac & Vascular Institute - Miami
- Advent Health Orlando - Orlando
Georgia
- Emory - Atlanta
- Piedmont Heart Institute - Atlanta
Michigan
- Ascension St. John Hospital - Detroit
- Beaumont Hospital, Royal Oak - Royal Oak
New York
- St. Joseph's Hospital - Liverpool
- NYU Langone - New York
California
- UCLA - Los Angeles
Illinois
- Loyola University Chicago - Maywood
Indiana
- Ascension St. Vincent - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2020-06-23 |
| Est. Completion | 2022-06-23 |
| Phase | Phase 3 |
What the finished NCT04248868 record still lists
NCT04248868 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 3,056-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Pulmonary Embolism appearing as the primary indexed condition, and to 2 interventions - of which r-tPA is the first listed.
NCT04248868 lists 19 locations in 13 states (Pennsylvania, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT04248868 about?
NCT04248868 is a clinical study titled "tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden". To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism.
What is the current status of trial NCT04248868?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 109 participants. The study started on 2020-06-23. Estimated completion is 2022-06-23.
What conditions does trial NCT04248868 study?
This clinical trial studies the following conditions: Pulmonary Embolism.
What interventions are being tested in trial NCT04248868?
The interventions under investigation include: r-tPA (DRUG), The Bashir™ Endovascular Catheter (DEVICE).
Who is sponsoring clinical trial NCT04248868?
This trial is sponsored by Thrombolex, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04248868 being conducted?
This trial has 19 study locations across California, Florida, Georgia, Illinois, Indiana. 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 NCT04248868's enrollment target sits among peer trials
109 35th of 48 higher than 14 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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