drugset / Trial / NCT04248868
tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden
Phase 3
Completed
109 enrolled
Thrombolex, Inc.
National Heart, Lung, and Blood Institute (NHLBI) · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-06-23
- Primary completion
- 2022-06-22
- Completion
- 2022-06-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alteplase | Protein / enzyme biologic | 7 mg | Other |