What side effects are associated with this type of intervention?

Common side effects of catheter-directed thrombolysis using r-tPA for Acute Pulmonary Embolism include bleeding complications (ranging from minor to major, such as intracranial hemorrhage), allergic reactions, hypotension, and reperfusion arrhythmias. Mechanical delivery of r-tPA may also lead to vascular injury, infection, and catheter-related complications.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Pulmonary Embolism (PE) that involve the use of thrombolytic agents and mechanical catheter-directed therapies. One notable example is the use of recombinant tissue plasminogen activator (r-tPA), such as alteplase, which is a thrombolytic agent used to dissolve blood clots. Mechanical catheter-directed therapies, like the EKOS Endovascular System, combine ultrasound with the delivery of thrombolytic drugs to enhance clot dissolution. These treatments aim to improve outcomes by directly targeting the clot, similar to the approach being studied with the Bashir™ Endovascular Catheter and r-tPA.

What other types of research exist?

Promising novel alternatives for treating acute pulmonary embolism in 2024 include: 1) Ultrasound-assisted catheter-directed thrombolysis (USAT), which uses ultrasound waves to enhance the penetration of thrombolytic drugs into the clot. 2) Mechanical thrombectomy devices such as the FlowTriever System, which physically removes clots without the need for thrombolytic drugs. 3) Newer pharmacological agents like tenecteplase, a genetically modified variant of tPA, which has shown potential for better efficacy and safety profiles in dissolving clots.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

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

0 / 12Eligibility criteria met

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.