The PEERLESS Study
NCT05111613 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 692
Last updated 2025-11-13
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
- Pulmonary Embolism
- Pulmonary Thromboembolism
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
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