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Anticoagulant

FlowTriever System + Anticoagulation for Pulmonary Embolism

N/A

Recruiting

Led By Jay Giri, MD

Research Sponsored by Inari Medical

Eligibility Criteria Checklist

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

Must have

At least two additional risk factors, identified by at least one measure in two separate categories noted below: a. Hemodynamic: i. SBP 90-100mmHg ii. Resting heart rate > 100 bpm b. Biomarker: i. Elevated* cardiac troponin (troponin I or troponin T, conventional or high sensitivity) ii. Elevated* BNP or NT-proBNP iii. Elevated venous lactate ≥2 mmol/L * Elevated, meaning at or above the upper limit of normal, per local standards for the assay used c. Respiratory: i. O2 saturation < 90% on room air ii. Supplemental O2 requirement ≥ 4 L/min iii. Respiratory rate ≥ 20 breaths/min iv. mMRC score > 0

Age at enrollment ≥ 18 years

Must not have

Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis, per 2019 ESC Guidelines1

Unable to be anticoagulated with heparin, enoxaparin or other parenteral antithrombin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the 48-hour, 1-month, and 3-month visits

Awards & highlights

No Placebo-Only Group

Summary

This trial compares treatments for a type of blood clot in the lungs: one with a new device plus anticoagulation vs. anticoagulation alone.

Who is the study for?

The PEERLESS II Study is for adults over 18 with a recent pulmonary embolism (PE) diagnosis, specific heart dysfunction due to PE, and additional risk factors like low blood pressure or elevated heart rate. People can't join if they've had certain advanced treatments for PE in the last month, have severe conditions limiting life expectancy, are pregnant, or have contraindications to the FlowTriever System or anticoagulants.

What is being tested?

This trial tests the FlowTriever System plus standard blood thinners against blood thinners alone in treating intermediate-risk acute PE. Participants will be randomly assigned to one of these two approaches to compare effectiveness and safety.

What are the potential side effects?

Potential side effects may include those related to the FlowTriever procedure such as bleeding or vessel damage and those from anticoagulation agents like bruising, bleeding disorders, allergic reactions to contrast agents used during imaging procedures.

Eligibility Criteria

Inclusion Criteria

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

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I have at least two risk factors from different categories related to heart, blood markers, or breathing.

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I am 18 years old or older.

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I have a confirmed blockage in a major lung artery.

Exclusion Criteria

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

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

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I cannot take blood thinners like heparin or enoxaparin.

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My heart has irregular beats that medicine can't control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the 48-hour, 1-month, and 3-month visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the 48-hour, 1-month, and 3-month visits

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the 48-hour, 1-month, and 3-month 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, which are assessed post-randomization

Secondary study objectives

Bailout therapy

Clinical deterioration

Composite clinical endpoint constructed as a win ratio hierarchy of the following three components, assessed post randomization

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: FlowTrieverActive Control1 Intervention

Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Group II: AnticoagulationActive Control1 Intervention

Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. Anticoagulants are a group of medications that decrease your blood's ability to clot.

0 / 6Eligibility criteria met