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Thrombolytic Agent

Thrombolysis vs FlowTriever System for Pulmonary Embolism (PEERLESS Trial)

N/A
Waitlist Available
Led By Stefan Stortecky, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 hour and 30 day visits
Awards & highlights

PEERLESS Trial Summary

This trial is comparing a new device to a standard treatment for pulmonary embolism, in patients who can't have the standard treatment.

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.Check my eligibility
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.See study design
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.

PEERLESS Trial 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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My treatment is set to start within 72 hours after my PE diagnosis or hospital transfer.
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My symptoms started within 14 days after my PE was confirmed.
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My heart and blood circulation are stable.
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I have had heart or lung issues, including high heart rate or low blood pressure at diagnosis.

PEERLESS Trial 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

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
Secondary outcome measures
All cause mortality
All-cause mortality
Change in right-ventricular/left-ventricular (RV/LV) ratio, as measured by echocardiography or CT
+12 more

PEERLESS 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
~110

Find a Location

Who is running the clinical trial?

Inari MedicalLead Sponsor
10 Previous Clinical Trials
3,801 Total Patients Enrolled
8 Trials studying Pulmonary Embolism
3,001 Patients Enrolled for Pulmonary Embolism
Stefan Stortecky, MDPrincipal InvestigatorBern University Hospital
3 Previous Clinical Trials
21,289 Total Patients Enrolled
1 Trials studying Pulmonary Embolism
800 Patients Enrolled for Pulmonary Embolism
Carin Gonsalves, MDPrincipal InvestigatorThomas Jefferson University
2 Previous Clinical Trials
76 Total Patients Enrolled

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

Frequently Asked Questions

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

How many individuals are receiving treatment through this trial?

"Affirmative. According to clinicaltrials.gov, this trial is still in search of participants since it was first posted on February 14th 2022 and last updated November 9th later that year. The study requires the enrolment of 550 patients from 58 separate medical sites."

Answered by AI

Is there capacity for additional participants in this research endeavor?

"The latest information from clinicaltrials.gov confirms that recruitment for this medical trial is ongoing. It was posted in mid-February 2022 and the data was recently updated on November 9th of the same year."

Answered by AI

In what areas can participants access this research project?

"At this time, 58 medical centres are welcoming participants for enrolment. These sites span from Wilmington to Elk Grove Village and West Columbia as well as dozens of other places inbetween. To reduce the burden of travelling, we advise selecting a facility close by when signing up."

Answered by AI
~0 spots leftby Mar 2024