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NCT03927508 · ClinicalTrials.gov registry record · Phase 1

First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism

A Phase 1 study of Pulmonary Embolism, sponsored by Thrombolex.

Completed
Registry status
Phase 1
Development phase
9
Enrollment target
5
Study locations

NCT03927508: Completed Phase 1 study of Pulmonary Embolism, sponsored by Thrombolex.

NCT03927508 is a Phase 1 study of Pulmonary Embolism that has completed, run by Thrombolex. The registered enrollment target is 9 participants, below the 3,058-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (100% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03927508, a Phase 1 study of Pulmonary Embolism, has completed, sponsored by Thrombolex.

COMPLETED
Registry status
Phase 1
Development phase
9 participants
Enrollment target
5
Study locations

Study Summary

The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.

Primary Outcome

Major Bleeding as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r-tPA administration. Bleeding criteria are as follows: Major Bleeding in Non-Surgical Patients 1. Fatal bleeding; and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL

Conditions Studied

Pulmonary Embolism

Interventions

  • DRUG r-tPA
  • DEVICE The Bashir™ Endovascular Catheter

Study Locations (5)

Pennsylvania

  • University Pittsburg Medical Center - Hamot - Erie
  • Temple University Hospital - Philadelphia

Florida

  • Advent Health Orlando - Orlando

Indiana

  • St Vincent Hospital and Health Care Center, Inc. - Indianapolis

New York

  • Columbia University Medical Center - Presbyterian - New York - New York

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2019-03-14
Est. Completion 2020-01-23
Phase Phase 1
Thrombolex

2 total trials

What the finished NCT03927508 record still lists

NCT03927508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 3,058-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (100% 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.

NCT03927508 lists 5 locations in 4 states (Pennsylvania, Florida, Indiana).

Frequently Asked Questions

What is clinical trial NCT03927508 about?

NCT03927508 is a clinical study titled "First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism". The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.

What is the current status of trial NCT03927508?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2019-03-14. Estimated completion is 2020-01-23.

What conditions does trial NCT03927508 study?

This clinical trial studies the following conditions: Pulmonary Embolism.

What interventions are being tested in trial NCT03927508?

The interventions under investigation include: r-tPA (DRUG), The Bashir™ Endovascular Catheter (DEVICE).

Who is sponsoring clinical trial NCT03927508?

This trial is sponsored by Thrombolex, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03927508 being conducted?

This trial has 5 study locations across Florida, Indiana, New York, Pennsylvania. 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 NCT03927508's enrollment target sits among peer trials

9 49th of 48 the lowest 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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Related registry views

Source: ClinicalTrials.gov NCT03927508, the US trial registry maintained by the National Library of Medicine. NCT03927508 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.