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Device

BEC Catheter for Pulmonary Embolism

N/A
Waitlist Available
Led By Parth Rali, MD
Research Sponsored by Temple University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 to ≤ 75 years of age
Be older than 18 years old
Must not have
INR > 1.5 if currently on warfarin (Coumadin®)
SBP < 90 mmHg > 15 minutes within two (2) hours prior to BEC procedure and is not resolved with IV fluids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights
No Placebo-Only Group

Summary

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

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include bleeding complications due to clot-dissolving medications delivered by the catheter. There might also be risks associated with catheter insertion such as infection or damage to blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My INR is above 1.5 and I am taking warfarin.
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My blood pressure stayed below 90 mmHg for over 15 minutes, not fixed by IV fluids.
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I have not had a stroke or mini-stroke in the past year.
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I am on medication to raise my blood pressure.
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I experienced a cardiac arrest requiring CPR during this hospital stay.
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I needed a temporary pacemaker or medication to support my heart due to a very slow heartbeat.
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My blood pressure is not higher than 175/110 mmHg, even with medication.
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I do not have brain conditions that could cause bleeding.
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I cannot take blood thinners due to severe side effects or risks.
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I have a bleeding disorder.
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I have permanent nerve damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Safety Endpoint, major bleeding, as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of rtPA infusion. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation
Reduction in RV/LV diameter ratio as measured by contrast enhanced chest CT from baseline within 48 ± 6 hours of initiation of treatment. chest CT (CTA) within 48 hours after the completion of r-tPA treatment
Secondary study objectives
Adverse events
All-cause mortality
Cardiac output (CO by Modified Fick calculation) and cardiac index (CI) following completion of the r-tPA pulse
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Acute Pulmonary Embolism (APE) involve the use of thrombolytic agents like recombinant tissue plasminogen activator (r-tPA), which work by breaking down the fibrin in blood clots, thereby dissolving them. Mechanical catheter delivery systems, such as the Bashir™ Endovascular Catheter, enhance this process by directly administering r-tPA to the site of the clot, ensuring higher local concentrations and more effective clot dissolution. This targeted approach is crucial for APE patients as it can rapidly restore blood flow, reduce right ventricular strain, and improve overall hemodynamic stability, thereby reducing the risk of complications and improving survival rates.
Improvements in pulmonary artery pressure and right ventricular function after ultrasound-accelerated catheter-directed thrombolysis for the treatment of pulmonary embolism.

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Who is running the clinical trial?

Temple UniversityLead Sponsor
315 Previous Clinical Trials
88,881 Total Patients Enrolled
Parth Rali, MDPrincipal InvestigatorTemple University
~0 spots leftby Nov 2024
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