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NOT YET RECRUITING
NCT06433011
NA

The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism

Sponsor: Thrombolex, Inc.

View on ClinicalTrials.gov

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

Interventions

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.

DRUG

r-tPA

Pulse spray and infusion