What side effects are associated with this type of intervention?

Mechanical thrombectomy, such as the FlowTriever System, is generally well-tolerated but can have side effects including vascular injury, bleeding, and, rarely, device-related complications. Catheter-directed thrombolysis (CDT) can lead to bleeding complications, including intracranial hemorrhage, and potential damage to the blood vessels. Anticoagulants, commonly used in PE treatment, can cause bleeding, ranging from minor bruising to severe hemorrhage. Each treatment option should be carefully considered by a healthcare provider based on the patient's specific condition and risk factors.

What prior FDA approvals exist?

The FDA has approved several treatments for Pulmonary Embolism (PE), including anticoagulants like heparin, warfarin, and newer direct oral anticoagulants (DOACs) such as rivaroxaban and apixaban. Mechanical thrombectomy devices, such as the FlowTriever System, have also been approved for the treatment of acute PE. These devices physically remove clots from the pulmonary arteries and are particularly useful for patients who cannot receive thrombolytic therapy due to contraindications.

What other types of research exist?

Promising novel alternatives to the FlowTriever System for pulmonary embolism treatment include catheter-directed thrombolysis (CDT) and other mechanical thrombectomy devices. Additionally, ongoing clinical trials and emerging therapies may offer new options, but specific details on these were not provided in the context.

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Thrombolytic Agent

Thrombolysis vs FlowTriever System for Pulmonary Embolism (PEERLESS Trial)

N/A

Waitlist Available

Led By Carin Gonsalves, MD

Research Sponsored by Inari Medical

Eligibility Criteria Checklist

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

Must have

Clinical signs and symptoms consistent with acute PE, or PESI class III-V, or sPESI ≥1

Age ≥ 18 years

Must not have

Unable to anticoagulate with heparin, enoxaparin or other parenteral antithrombin

Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis, per ESC 2019 guidelines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 24 hour and 30 day visits

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device called the FlowTriever System, which removes lung blood clots without using drugs. It is for patients with acute pulmonary embolism who can't use clot-dissolving medications. The FlowTriever System allows for the nonsurgical removal of clots.

Who is the study for?

The PEERLESS Study is for adults over 18 with a recent pulmonary embolism (PE) diagnosis, showing specific heart or lung issues but are hemodynamically stable. They should be able to start treatment within 72 hours of diagnosis and have symptoms that started within the past two weeks. Exclusions include sensitivity to contrast agents, certain heart conditions, life expectancy under 30 days, participation in other trials, inability to use anticoagulants like heparin, or chronic thromboembolic diseases.

What is being tested?

This study compares the FlowTriever System against Catheter-Directed Thrombolysis (CDT) for treating acute PE. It's a forward-looking trial conducted across multiple centers where participants are randomly assigned to either intervention. There's also a group who can't receive thrombolysis due to contraindications; they'll only get the FlowTriever treatment.

What are the potential side effects?

Potential side effects from these interventions may include bleeding complications, allergic reactions to contrast dye used during procedures, damage at the catheter insertion site, irregular heartbeat or arrhythmias related to the procedure itself.

Eligibility Criteria

Inclusion Criteria

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

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I show signs of a severe pulmonary embolism.

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I am 18 years old or older.

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I have had heart or lung issues, including high heart rate or low blood pressure at diagnosis.

Exclusion Criteria

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

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I cannot use certain blood thinners like heparin.

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I have or had chronic lung blood clot issues as per 2019 guidelines.

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My initial symptoms included severe instability in my blood pressure or heart rate.

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I cannot or do not want to follow the required visit schedule.

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I received clot-dissolving treatment or a clot removal procedure for my PE within the last 48 hours.

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My heart has irregular beats that haven't improved with treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 24 hour and 30 day visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 24 hour and 30 day visits

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 hour and 30 day visits for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Composite clinical endpoint constructed as a win ratio, a hierarchy of the following

Secondary study objectives

Composite clinical endpoint constructed as a win ratio hierarchy of the following four components

Modified Medical Research Council (mMRC) dyspnea score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Non-Randomized Absolute Contraindication to Thrombolytics CohortExperimental Treatment1 Intervention

Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Group II: Randomized Controlled Trial Cohort - FlowTriever ArmActive Control1 Intervention

Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Group III: Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis ArmActive Control1 Intervention

Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FlowTriever System

2016

N/A

~1850

0 / 9Eligibility 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

Mechanical thrombectomy, such as the FlowTriever System, physically removes clots from the pulmonary arteries, providing rapid restoration of blood flow and oxygenation, which is crucial for patients with severe or life-threatening pulmonary embolism. This contrasts with anticoagulation, which prevents new clots and allows the body to dissolve existing clots over time, and thrombolysis, which uses drugs to quickly dissolve clots. The choice of treatment depends on the severity of the embolism, patient stability, and specific contraindications, making it essential to tailor the approach to each patient's needs.