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The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism
Sponsor: Thrombolex, Inc.
Summary
To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the pulmonary arteries for the treatment of intermediate risk pulmonary embolism (PE).
Official title: The RAPID - PE Study: RESCUE Advanced Protocol Without ICU Stay and no Lytic Drip - for the Treatment of Pulmonary Embolism
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2024-06-25
Completion Date
2027-08-25
Last Updated
2024-05-29
Healthy Volunteers
No
Conditions
Interventions
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.
r-tPA
Pulse spray and infusion