Thrombolysis vs FlowTriever System for Pulmonary Embolism (PEERLESS Trial)

Palo Alto (17 mi)

Overseen byCarin Gonsalves, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

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.

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.

I have had heart or lung issues, including high heart rate or low blood pressure at diagnosis.

Exclusion Criteria

I cannot use certain blood thinners like heparin.

I have or had chronic lung blood clot issues as per 2019 guidelines.

My initial symptoms included severe instability in my blood pressure or heart rate.

I cannot or do not want to follow the required visit schedule.

I received clot-dissolving treatment or a clot removal procedure for my PE within the last 48 hours.

My heart has irregular beats that haven't improved with treatment.

Treatment Details

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.

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)