20 Participants Needed

BEC Catheter for Pulmonary Embolism

LM
MR
Overseen ByMichael R Jacobs, PharmD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

PR

Parth Rali, MD

Principal Investigator

Temple University

Are You a Good Fit for This Trial?

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.
See 2 more

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.
See 22 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Patients who present with PEExperimental Treatment1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials
321
Recruited
89,100+
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