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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

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 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

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
~660

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.

Find a Location

Who is running the clinical trial?

Inari MedicalLead Sponsor
14 Previous Clinical Trials
4,361 Total Patients Enrolled
9 Trials studying Pulmonary Embolism
3,391 Patients Enrolled for Pulmonary Embolism
Carin Gonsalves, MDPrincipal InvestigatorThomas Jefferson University
2 Previous Clinical Trials
76 Total Patients Enrolled
Wissam Jaber, MDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
18 Total Patients Enrolled
1 Trials studying Pulmonary Embolism
18 Patients Enrolled for Pulmonary Embolism

Media Library

Catheter-Directed Thrombolysis (Thrombolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05111613 — N/A
Pulmonary Embolism Research Study Groups: Randomized Controlled Trial Cohort - FlowTriever Arm, Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, Non-Randomized Absolute Contraindication to Thrombolytics Cohort
Pulmonary Embolism Clinical Trial 2023: Catheter-Directed Thrombolysis Highlights & Side Effects. Trial Name: NCT05111613 — N/A
Catheter-Directed Thrombolysis (Thrombolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05111613 — N/A
~153 spots leftby Sep 2025
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