Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06588634

The PERSEVERE Study

Led by Inari Medical · Updated on 2026-05-08

200

Participants Needed

26

Research Sites

163 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care

CONDITIONS

Official Title

The PERSEVERE Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age at enrollment 518 years
  • Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
  • High-risk class of acute pulmonary embolism
  • Right ventricular dysfunction, defined as RV/LV ratio 1.0
  • Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent as a third option (Europe and UK sites only)
Not Eligible

You will not qualify if you...

  • Prolonged cardiac arrest with loss of consciousness associated with neurological deficit
  • Investigator's opinion that the patient is not appropriate for catheter-based intervention
  • Known pre-existing chronic thromboembolic pulmonary hypertension or imaging signs of chronic pulmonary embolism
  • Recent stroke (less than 14 days)
  • Recent cranial or spinal surgery (less than 14 days)
  • Life-threatening active bleeding or hemorrhage in a critical area
  • Known intracranial tumor
  • End-stage medical condition with life expectancy less than 3 months
  • Known sensitivity to radiographic contrast agents that cannot be pre-treated
  • Inability to anticoagulate or known heparin-induced thrombocytopenia
  • Current participation in another drug or device study that may interfere with this trial
  • Ventricular arrhythmias refractory to treatment at enrollment
  • Condition that may compromise well-being or confound assessments, including contraindication to FlowTriever use
  • Part of a vulnerable population (pregnant, breastfeeding, incarcerated)
  • Previously enrolled in this study
  • Received thrombolytic or thrombectomy therapy for index pulmonary embolism within 30 days prior to randomization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 26 locations

1

Yale University

New Haven, Connecticut, United States, 06519

Actively Recruiting

2

Orlando Health Regional Medical Center

Orlando, Florida, United States, 32806

Actively Recruiting

3

Sarasota Memorial Hospital

Sarasota, Florida, United States, 34239

Actively Recruiting

4

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

5

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

Actively Recruiting

6

Northwell Health

Bay Shore, New York, United States, 11706

Actively Recruiting

7

SUNY, The University at Buffalo

Buffalo, New York, United States, 14203

Actively Recruiting

8

Summa Akron

Akron, Ohio, United States, 44304

Actively Recruiting

9

UPHS Penn Health System

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

10

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

Actively Recruiting

11

HCA Tristar/Centennial

Nashville, Tennessee, United States, 37203

Actively Recruiting

12

HCA Medical City Heart & Spine

Dallas, Texas, United States, 75039

Actively Recruiting

13

HCA Methodist Health San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

14

Besançon University Hospital

Besançon, France, 25030

Actively Recruiting

15

Hopital Arnaud de Villeneuve, Montpellier

Montpellier, France

Actively Recruiting

16

CHU Nîmes Caremeau

Nîmes, France

Actively Recruiting

17

Hôpital Européen Georges-Pompidou, Paris

Paris, France

Actively Recruiting

18

Klinikum Chemnitz

Chemnitz, Germany

Actively Recruiting

19

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Germany

Actively Recruiting

20

Universitätsmedizin Mainz

Mainz, Germany, 55131

Actively Recruiting

21

Munich LMU

München, Germany

Actively Recruiting

22

Universitätsklinik Regensburg

Regensburg, Germany

Actively Recruiting

23

Hospital Universitari Vall d'Hebron, Barcelona

Barcelona, Spain

Actively Recruiting

24

Hospital Universitario La Paz Madrid

Madrid, Spain, 28046

Actively Recruiting

25

University Hospital Basel

Basel, Switzerland, 4031

Actively Recruiting

26

Royal Free Hospital London

London, United Kingdom

Actively Recruiting

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Research Team

T

Tine Devolder

CONTACT

J

Jen Foss

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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