The PEERLESS Study

NCT05111613 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 692

Last updated 2025-11-13

Study results available
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Summary

A prospective, multicenter, randomized controlled trial of the FlowTriever System compared to Catheter-Directed Thrombolysis (CDT) for use in the treatment of acute pulmonary embolism. The trial includes a non-randomized cohort of subjects with an absolute contraindication to thrombolysis.

Conditions

Interventions

DEVICE

Catheter-Directed Thrombolysis

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

DEVICE

FlowTriever System

Mechanical thrombectomy for pulmonary embolism

Sponsors & Collaborators

  • Inari Medical

    lead INDUSTRY

Principal Investigators

  • Wissam Jaber, MD · Emory University

  • Carin Gonsalves, MD · Thomas Jefferson University

  • Stefan Stortecky, MD · Bern University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2024-03-01
Completion
2024-04-11
FDA Device
Yes

Countries

  • United States
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05111613 on ClinicalTrials.gov