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NCT06588634NARecruiting

The PERSEVERE Study

Inari Medical

Start Date

12/16/2024

Completion Date

2/1/2028

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Age at enrollment ≥18 years 2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery 3. High-risk class of acute PE 4. RV dysfunction, as defined RV/LV ratio ≥1.0 5. 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 (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards Exclusion Criteria: 1. Prolonged cardiac arrest with loss of consciousness associated with neurological deficit. 2. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention 3. Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH 4. Recent stroke (\<14 days) 5. Recent cranial or spinal surgery (\<14 days) 6. Life-threatening active bleeding or hemorrhage into a critical area 7. Known intracranial tumor 8. End-stage medical condition with life expectancy \<3 months (irrespective of the severity of acute PE), as determined by the Investigator 9. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated 10. Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT) 11. Current participation in another drug or device study that may interfere with the conduct of this trial 12. Ventricular arrhythmias refractory to treatment at the time of enrollment 13. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments), including a contraindication to use of FlowTriever System per local approved labeling 14. Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions 15. Subject was previously enrolled in this study 16. Subject has received prior thrombolytic (systemic or catheter-directed) therapy for any reason or thrombectomy (surgical or catheter-based) therapy for index PE, within 30 days prior to randomization

Interventions

DEVICE

FlowTriever System

PROCEDURE

Standard of Care

Interested in This Trial?

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Conditions

Pulmonary EmbolismPulmonary Thromboembolism

Locations

Yale University

New Haven, Connecticut 06519

United States

AdventHealth Orlando

Orlando, Florida 32803

United States

Orlando Health Regional Medical Center

Orlando, Florida 32806

United States

Sarasota Memorial Hospital

Sarasota, Florida 34239

United States

Emory University

Atlanta, Georgia 30322

United States

University of Mississippi Medical Center

Jackson, Mississippi 39216

United States

Northwell Health

Bay Shore, New York 11706

United States

SUNY, The University at Buffalo

Buffalo, New York 14203

United States

Summa Akron

Akron, Ohio 44304

United States

UPHS Penn Health System

Philadelphia, Pennsylvania 19104

United States

UPMC

Pittsburgh, Pennsylvania 152123

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

HCA Tristar/Centennial

Nashville, Tennessee 37203

United States

HCA Medical City Heart & Spine

Dallas, Texas 75039

United States

HCA Methodist Health San Antonio

San Antonio, Texas 78229

United States

Besançon University Hospital

Besançon, 25030

France

Hopital Arnaud de Villeneuve, Montpellier

Montpellier,

France

CHU Nîmes Caremeau

Nîmes,

France

Hôpital Européen Georges-Pompidou, Paris

Paris,

France

Klinikum Chemnitz

Chemnitz,

Germany

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden,

Germany

Universitätsmedizin Mainz

Mainz, 55131

Germany

Munich LMU

München,

Germany

Universitätsklinik Regensburg

Regensburg,

Germany

Hospital Universitari Vall d'Hebron, Barcelona

Barcelona,

Spain

Hospital Universitario La Paz Madrid

Madrid, 28046

Spain

University Hospital Basel

Basel, 4031

Switzerland

Royal Free Hospital London

London,

United Kingdom