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

NCT03927508 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-03-30

Study results available
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Summary

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

Conditions

Interventions

DRUG

r-tPA

Pulse spray and infusion

DEVICE

The Bashir™ Endovascular Catheter

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

Sponsors & Collaborators

  • Thrombolex, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-14
Primary Completion
2019-12-19
Completion
2020-01-23
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03927508 on ClinicalTrials.gov