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Anticoagulant

FlowTriever System + Anticoagulation for Pulmonary Embolism

N/A

Recruiting

Led By Frances Mae West, 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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite clinical endpoint constructed as a win ratio, a hierarchy of the following, which are assessed post-randomization

Secondary outcome measures

6-minute walk distance

All-cause and PE-related mortality

All-cause and PE-related readmissions

+9 more

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Inari MedicalLead Sponsor

11 Previous Clinical Trials

3,161 Total Patients Enrolled

8 Trials studying Pulmonary Embolism

2,351 Patients Enrolled for Pulmonary Embolism

Frances Mae West, MDPrincipal InvestigatorJefferson Health,

Bernhard Gebauer, MDPrincipal InvestigatorCharité University Hospital Berlin

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what quantity of healthcare facilities is this experiment being conducted?

"Clinical trial sites for this study are available in thirty-three cities including Pasadena, Aurora, and Largo. Brookwood Medical Center, Huntington Memorial Hospital and University of Colorado Denver are some of the institutions taking part in the research."

Answered by AI

Is enrollment in this medical research endeavor still available?

"This specific clinical trial, posted on November 1st 2023 and amended September 20th of the same year, is not accepting new participants at this time. Nevertheless, 86 other studies are currently open for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The PEERLESS II Study

2023. "The PEERLESS II Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06055920.

All > Pulmonary Embolism > Spokane