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

Phase 1 Completed 9 enrolled Thrombolex, Inc.

NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2019-03-14
Primary completion: 2019-12-19
Completion: 2020-01-23

Publications

Sista AK, Bhatheja R, Rali P, Natarajan K, Green P, Piazza G, Comerota AJ, Parikh SA, Lakhter V, Bashir R, Rosenfield K. First-in-Human Study to Assess the Safety and Feasibility of the Bashir Endovascular Catheter for the Treatment of Acute Intermediate-Risk Pulmonary Embolism. Circ Cardiovasc Interv. 2021 Jan;14(1):e009611. doi: 10.1161/CIRCINTERVENTIONS.120.009611. Epub 2020 Dec 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	recombinant tissue-type plasminogen activator	Protein / enzyme biologic	12 mg	Other
Subject	recombinant tissue-type plasminogen activator	Protein / enzyme biologic	14 mg	Other

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

Summary

Timeline

Publications

Drugs

Indications