Thrombolysis vs FlowTriever System for Pulmonary Embolism

(PEERLESS Trial)

Recruiting in Palo Alto (17 mi)

+66 other locations

Overseen by Stefan Stortecky, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Inari Medical

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Wissam Jaber, MD

Principal Investigator

Emory University

Carin Gonsalves, MD

Principal Investigator

Thomas Jefferson University

Stefan Stortecky, MD

Principal Investigator

Bern University Hospital

Eligibility Criteria

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.

Inclusion Criteria

I show signs of a severe pulmonary embolism.

I am 18 years old or older.

My treatment is set to start within 72 hours after my PE diagnosis or hospital transfer.

Exclusion Criteria

You have been diagnosed with heparin-induced thrombocytopenia (HIT).

The doctor thinks you may not live for more than 30 days.

The doctor thinks that it's not suitable to use a catheter for treatment based on the imaging or other evidence.

Treatment Details

Interventions

• Catheter-Directed Thrombolysis (Thrombolytic Agent)
• FlowTriever System (Mechanical Thrombectomy Device)

Trial Overview 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.

Participant Groups

Group I: Non-Randomized Absolute Contraindication to Thrombolytics Cohort Experimental Treatment 1 Intervention

Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Group II: Randomized Controlled Trial Cohort - FlowTriever Arm Active Control 1 Intervention

Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Group III: Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm Active Control 1 Intervention

Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)

Who Is Running the Clinical Trial?

Inari Medical

Lead Sponsor

Trials

18

Recruited

5,300+