What side effects are associated with this type of intervention?

Common treatments for pulmonary embolism include anticoagulants, thrombolytics, and mechanical thrombectomy. Anticoagulants, such as heparin and warfarin, can cause bleeding complications, including gastrointestinal bleeding and hemorrhagic stroke. Thrombolytics, like alteplase, also carry a high risk of bleeding, including intracranial hemorrhage. Mechanical thrombectomy, such as the FlowTriever2 Catheter, is generally associated with fewer bleeding complications but can cause vascular injury, including vessel perforation, dissection, and access site complications. Additionally, there is a risk of embolization of thrombus fragments during the procedure.

What prior FDA approvals exist?

The FDA has approved several treatments for Pulmonary Embolism (PE), including anticoagulants like heparin and warfarin, and thrombolytics such as alteplase. In terms of mechanical thrombectomy, devices like the FlowTriever System have been approved for the removal of clots in the pulmonary arteries. The FlowTriever System, similar to the FlowTriever2 Catheter being studied, is designed to mechanically extract clots, providing an alternative to pharmacological treatments, especially in cases where rapid clot removal is critical.

What other types of research exist?

Promising alternatives to the FlowTriever2 Catheter for pulmonary embolism treatment include: 1) The Penumbra Indigo System, which is another mechanical thrombectomy device designed for rapid clot removal. 2) Ultrasound-assisted catheter-directed thrombolysis (USAT), which combines ultrasound energy with thrombolytic drugs to enhance clot dissolution. 3) The EkoSonic Endovascular System, which uses ultrasound waves to deliver thrombolytics more effectively. These alternatives have shown potential in improving outcomes for PE patients.

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Thrombectomy Device

FlowTriever2 Device for Pulmonary Embolism (FLARE-FT2 Trial)

N/A

Waitlist Available

Research Sponsored by Inari Medical

Eligibility Criteria Checklist

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

Must have

PE symptom duration ≤ 14 days

Clinical signs and symptoms consistent with acute PE

Must not have

History of uncompensated heart failure

History of heparin-induced thrombocytopenia (HIT) Any contraindication to systemic or therapeutic doses heparin or anticoagulants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the FlowTriever2 Catheter, a device designed to remove blood clots from blood vessels. It targets patients who have blood clots that can block blood flow and cause serious health problems. The catheter works by being inserted into the blood vessel to grab and remove the clot, helping to restore normal circulation.

Who is the study for?

This trial is for adults with a recent pulmonary embolism (PE), which is a blockage in the lungs. They should have symptoms for less than 14 days, an unstable heart rate, and evidence of PE on a CT scan. Participants must not be pregnant or nursing, have severe other illnesses like active cancer or bleeding disorders, or be on certain medications that could increase risks.

What is being tested?

The FlowTriever2 Catheter is being tested to see if it can safely remove blood clots from the lungs in patients with PE. This study involves one group of participants who will all receive this treatment without comparison to another intervention.

What are the potential side effects?

While specific side effects are not listed here, typical risks may include bleeding at the catheter entry site, damage to blood vessels where the clot is removed, allergic reactions to materials used during the procedure, and potential complications related to heart and lung function.

Eligibility Criteria

Inclusion Criteria

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

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My symptoms of pulmonary embolism have been present for 2 weeks or less.

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I am showing signs of a possible pulmonary embolism.

Exclusion Criteria

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

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I have a history of heart failure that is not well-managed.

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I have a history of bad reactions to heparin or cannot take blood thinners.

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My cancer is getting worse.

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I have had radiation therapy to my chest in the past.

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I have not had heart or lung surgery in the past week.

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I have a bleeding or clotting disorder.

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I am not pregnant or nursing.

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I need medication to maintain my blood pressure above 90 mmHg.

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I have a history of severe or long-term high blood pressure in the lungs.

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My heart's left chamber is weak, pumping less effectively.

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I need oxygen because of a lung condition.

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I need a lot of oxygen to maintain my blood oxygen levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours post procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Effectiveness: Change in Mean Pulmonary Arterial Pressure (mmHg)

Number of Major Bleeding Occurrences

Number of Patient Mortalities (48 hours)

+1 more

Secondary study objectives

Change in Systolic Pulmonary Arterial Pressure (mmHg)

Number of Adjunctive Thrombolytic Uses

Number of Device-Related Serious Adverse Events

+2 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: Completed CasesExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FlowTriever2 Catheter

2023

N/A

~50

0 / 14Eligibility 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 and anticoagulation therapy. Mechanical thrombectomy, such as the FlowTriever2 Catheter, physically removes the clot from the pulmonary arteries, rapidly restoring blood flow and improving oxygenation. This is crucial for patients with large or life-threatening clots, providing immediate relief and reducing the risk of right heart failure. Anticoagulation therapy prevents further clot formation and allows the body to naturally dissolve the existing clot over time, reducing the risk of recurrent embolism. Both treatments aim to mitigate complications, but mechanical thrombectomy offers a more immediate intervention, which can be life-saving in acute cases.