What side effects are associated with this type of intervention?

Mechanical thrombectomy, including devices like the FlowTriever, is generally associated with risks such as vascular injury, bleeding, and potential for embolization of thrombus fragments. Broader treatments for PE, such as anticoagulants (e.g., heparin, warfarin) and thrombolytics (e.g., tissue plasminogen activator), commonly cause bleeding complications, including major bleeding events, and in some cases, can lead to hemorrhagic stroke.

What prior FDA approvals exist?

The FDA has approved several treatments for Pulmonary Embolism (PE), including anticoagulants like heparin and warfarin, thrombolytics such as alteplase, and mechanical thrombectomy devices like the FlowTriever. The FlowTriever device is specifically designed for the mechanical removal of clots in patients with PE, offering an alternative to pharmacological treatments. This device represents a significant advancement in the interventional management of PE, providing a minimally invasive option for patients who may not be suitable candidates for anticoagulation or thrombolytic therapy.

What other types of research exist?

Promising novel alternatives to FlowTriever for pulmonary embolism treatment include: 1) The Indigo Aspiration System, which uses continuous aspiration to remove thrombus; 2) The AngioVac System, which employs a venous drainage cannula for thrombus removal; 3) Ultrasound-assisted catheter-directed thrombolysis (USAT), which combines ultrasound energy with thrombolytic drugs to enhance clot dissolution; and 4) The Penumbra System, which uses mechanical aspiration for thrombus removal. These alternatives have shown potential in recent clinical trials and studies.

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Device

FlowTriever Device for Pulmonary Embolism

N/A

Recruiting

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 18 years of age

Be older than 18 years old

Must not have

Inability to consent

Patients with active and severe COVID-19 infection (e.g. using ventilator, requiring hemodynamic support)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up length of index hospitalization, length of hospitalization median of 9.1 days, length of icu stay median 3.1 per jns

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device called FlowTriever to treat patients with certain types of blood clots in their lungs. These patients have clots that are not immediately life-threatening but still need treatment. The device works by physically removing the clots through a small, minimally invasive procedure. The FlowTriever System is the first FDA-approved mechanical thrombectomy device for treating pulmonary embolism, enabling nonsurgical removal of clots without thrombolytic medication.

Who is the study for?

This trial is for adults with low-risk submassive pulmonary embolism, which means they have certain heart strain or dilation and elevated heart-related proteins in their blood. They must be stable and not severely ill with COVID-19, pregnant, breastfeeding, unable to consent or take blood thinners.

What is being tested?

The study tests the FlowTriever device's effectiveness and safety in treating low-risk submassive pulmonary embolism by removing clots from lung arteries without surgery.

What are the potential side effects?

While specific side effects are not listed here, interventions like FlowTriever may cause discomfort at the insertion site, bleeding complications, or reactions related to clot removal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give consent by myself.

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I do not have a severe or active COVID-19 infection.

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I cannot use blood thinners like heparin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ length of index hospitalization, length of hospitalization median of 9.1 days, length of icu stay median 3.1 per jns

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~length of index hospitalization, length of hospitalization median of 9.1 days, length of icu stay median 3.1 per jns

This trial's timeline: 3 weeks for screening, Varies for treatment, and length of index hospitalization, length of hospitalization median of 9.1 days, length of icu stay median 3.1 per jns for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

ICU Length of Stay

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: FlowTrieverExperimental Treatment1 Intervention

0 / 4Eligibility 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 Pulmonary Embolism (PE) include mechanical thrombectomy, anticoagulation, and thrombolytic therapy. Mechanical thrombectomy, such as the FlowTriever device, physically removes the clot from the pulmonary arteries, rapidly restoring blood flow and reducing heart strain. Anticoagulation therapy prevents further clot formation and allows the body to naturally dissolve the existing clot. Thrombolytic therapy actively dissolves the clot using drugs like tissue plasminogen activator (tPA). These treatments are vital for PE patients as they quickly restore normal blood flow, reduce the risk of complications, and prevent recurrence.