First - In - Man Study to Assess the Safety & Feasibility of The Bashir™

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

The Bashir™ Endovascular Catheter has been designed to administer therapeutic agents in the peripheral vasculature. Because of the unique design of the catheter, with its six expandable infusion limbs, the Bashir™ Endovascular Catheter has the ability to: 1. Create a much larger central channel for blood flow, thereby utilizing the body's own endogenous fibrinolytic agents to lyse the clot, and 2. Greatly enhance the radial dispersion of a catheter-administered thrombolytic agent throughout the thrombus. Expansion of the multiple arms of the basket in the infusion catheter causes fissuring of the clot. The net result is that a greater surface area of clot is exposed to both endogenous and exogenously administered lytic agents, thereby promoting clot dissolution. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03927508
Study type	Interventional
Source	Thrombolex, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	March 14, 2019
Completion date	January 23, 2020

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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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms