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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing a new treatment for acute submassive pulmonary embolism, a blood clot in the lungs. The goal is to determine if the Bashir™ Endovascular Catheter (BEC) safely and effectively delivers medication directly into the lungs using a targeted approach. The trial seeks individuals who have experienced pulmonary embolism symptoms for 14 days or less and have a specific type of blood clot visible on a CT scan. Participants must be able to follow study procedures and attend follow-up appointments. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research and potentially benefit from a novel treatment approach.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot have used thrombolytics or certain blood thinners within 3 days before joining the study.

What prior data suggests that the Bashir™ Endovascular Catheter is safe for treating pulmonary embolism?

Research has shown that the Bashir™ Endovascular Catheter (BEC) is safe for treating blood clots in the lungs. In an earlier study, patients experienced "excellent safety" with this catheter. Among the first 50 patients treated, none had major bleeding or died within seven days. Another study also found no serious bleeding problems from using the BEC. These results suggest that the BEC is well-tolerated and safe for treating certain lung blood clots. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Bashir™ Endovascular Catheter (BEC) is unique because it targets pulmonary embolism (PE) by directly infusing therapeutic agents into the pulmonary artery, offering a more localized treatment compared to systemic anticoagulants like heparin or thrombolytic therapy. This catheter-based approach allows for targeted delivery, which can potentially reduce the risk of bleeding and other systemic side effects associated with traditional treatments. Researchers are excited about the BEC because it may improve the precision and effectiveness of PE treatment, offering faster relief and potentially better outcomes for patients.

What evidence suggests that the Bashir™ Endovascular Catheter is effective for treating acute submassive pulmonary embolism?

Research shows that the Bashir™ Endovascular Catheter (BEC), which participants in this trial will receive, effectively treats acute submassive pulmonary embolism (PE), a type of blood clot in the lungs. Studies have found that it reduces the size difference between the heart's right and left chambers, indicating successful treatment. In one study, no patients died or experienced serious heart issues within a week after the procedure. The treatment is generally safe, with few cases of major bleeding. Overall, the BEC safely improves heart function and clears blockages in the lung's blood vessels. ^{1 2 4 5 6}

Who Is on the Research Team?

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.

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 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?

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+

Citations

1. jvascsurg.org jvascsurg.org/article/S0741-5214(25)00163-6/fulltext

Outcomes of the Bashir Endovascular Catheter ... This is a retrospective observational case-series study of 10 patients with intermediate-risk PE who received the on-the-Table thrombolytic infusion with the ...

2. jacc.org jacc.org/doi/10.1016/j.jcin.2022.09.011

Bashir Catheter–Directed Thrombolysis for Acute ... PM-CDT with the Bashir endovascular catheter is associated with a significant reduction in RV/LV diameter ratio and very low bleeding and adverse event rates.

3. citoday.com citoday.com/news/thrombolex-bashir-catheter-for-acute-pe-studied-in-interim-analysis-of-rapid-pe-1

Thrombolex Bashir Catheter for Acute PE Studied in Interim ... At 7 days, no patients had death or hemodynamic decompensation (the study's primary endpoint). · Major bleeding was seen in 2% of patients—one ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.120.009611

First-in-Human Study to Assess the Safety and Feasibility ... This First-in-Human study demonstrated the feasibility of the Bashir Endovascular Catheter in patients with acute intermediate-risk pulmonary embolism.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12149391/

Safety and Feasibility of On-the-Table Pharmacomechanical ... On-the-table PML using the Bashir catheter effectively reduced RV/LV ratio and PA obstruction. The procedure was safe, with no major bleeding complications.

6. vascularspecialistonline.com vascularspecialistonline.com/interim-rapid-pe-study-reveals-excellent-safety-data-in-first-50-patients/

Interim RAPID-PE study reveals 'excellent' safety data in ... Prespecified interim analysis data from the first 50 patients in RAPID-PE have demonstrated “excellent safety” and “remarkably efficient lab ...