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Mechanical Thrombectomy Device

FlowTriever System for Pulmonary Embolism

N/A

Recruiting

Led By Stavros Konstantinides, MD PhD

Research Sponsored by Inari Medical

Eligibility Criteria Checklist

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

Must have

Age at enrollment ≥18 years

High-risk class of acute PE

Must not have

Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH

Life-threatening active bleeding or hemorrhage into a critical area

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the earlier of initial hospital discharge or 7 days after randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial compares the use of the FlowTriever System to the standard treatment for high-risk pulmonary embolism.

Who is the study for?

The PERSEVERE study is for adults over 18 with a high-risk class of acute pulmonary embolism (PE), which means they have a blockage in the lung's main artery. They must also show right ventricle dysfunction due to this condition and be able to start treatment within 4 hours of diagnosis.

What is being tested?

This randomized controlled trial compares two treatments for severe PE: the standard care typically given for such cases versus an intervention using the FlowTriever System, which is designed to remove blood clots from the arteries in the lungs.

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, or other complications related to clot removal procedures. Standard care side effects depend on the exact treatment but can include bleeding from anticoagulants.

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.

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My condition is classified as high-risk pulmonary embolism.

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I can start the treatment within 4 hours of being chosen.

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 chronic blood clots in my lungs.

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I am not currently experiencing any severe bleeding.

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I have a known brain tumor.

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I have had a severe heart attack that caused me to lose consciousness or have neurological issues.

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I cannot take blood thinners or have a bad reaction to heparin.

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I have not had a stroke in the last 14 days.

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I have not had brain or spine surgery in the last 14 days.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the earlier of initial hospital discharge or 7 days after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the earlier of initial hospital discharge or 7 days after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and the earlier of initial hospital discharge or 7 days after randomization 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 of the following adjudicated events

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

Group II: Standard of CareActive Control1 Intervention

0 / 11Eligibility criteria met

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Who is running the clinical trial?

Inari MedicalLead Sponsor

16 Previous Clinical Trials

5,439 Total Patients Enrolled

11 Trials studying Pulmonary Embolism

4,469 Patients Enrolled for Pulmonary Embolism

Stavros Konstantinides, MD PhDPrincipal InvestigatorCenter for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg-University Mainz, Germany

Jay Giri, MD, MPHPrincipal InvestigatorPenn Medicine, Philadelphia, PA, USA

Nicolas Meneveau, MD PhDPrincipal InvestigatorCentre Hospitalier Universitaire Hôpital Jean Minjoz, Besançon, France

John M Moriarty, MDPrincipal InvestigatorWestwood Imaging Center & Interventional Radiology Clinic - UCLA, CA, USA