BEC Catheter for Pulmonary Embolism

Overseen By Michael R Jacobs, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Temple University

Must not be taking: Thrombolytics, Glycoprotein IIb/IIIa

Disqualifiers: CVA, Head trauma, Active bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a special device that helps treat serious blood clots in the lungs by quickly and effectively breaking them down.

Research Team

Parth Rali, MD

Principal Investigator

Temple University

Eligibility Criteria

This trial is for adults aged 18-75 with a recent (≤14 days) pulmonary embolism, confirmed by CT scan, who can consent to treatment. They must have certain heart imaging findings and be able to follow study procedures. Exclusions include severe bleeding risks, pregnancy, major surgery within the past two weeks, and other specific health conditions.

Inclusion Criteria

Willing and able to provide informed consent

Willing and able to comply with all study procedures and follow-up

Your heart's right ventricle is significantly larger compared to the left ventricle, as shown by a special heart imaging test.

Exclusion Criteria

My INR is above 1.5 and I am taking warfarin.

Your blood's ability to clot takes longer than 50 seconds when not taking any blood thinning medication.

I have not had major surgery in the last 2 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Administration of pharmaco-mechanical catheter directed therapy using pulse spray of r-tPA for the treatment of acute submassive pulmonary embolism

48 hours

In-hospital procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of RV/LV diameter ratio and adverse events

30 days

Treatment Details

Interventions

• The Bashir™ Endovascular Catheter (BEC)

Trial Overview The RESCUE II Study tests the Bashir™ Endovascular Catheter's safety and effectiveness in delivering targeted medication directly to blood clots in the lungs using a special pulse spray technique for patients with acute submassive pulmonary embolism.

Participant Groups

Group I: Patients who present with PE Experimental Treatment 1 Intervention

The Bashir™ Endovascular Catheter (BEC) is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. Two sizes of BECs will be used in this study

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+