RECRUITING

The PERSEVERE Study

Conditions

Pulmonary Embolism Pulmonary Thromboembolism PE FlowTriever CDT Catheter Directed Thrombolysis Anticoagulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

The PERSEVERE Study

Quick Facts

Study Start:2024-12-16

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06588634

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Tine Devolder

CONTACT

+32 476 53 88 05

tine.devolder@inarimedical.com

Jen Foss

CONTACT

978-587-6598

jenifer.foss@stryker.com

Principal Investigator

Nicolas Meneveau, MD PhD

PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Hôpital Jean Minjoz, Besançon, France

Stavros Konstantinides, MD PhD

PRINCIPAL_INVESTIGATOR

Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg-University Mainz, Germany

John M Moriarty, MD

PRINCIPAL_INVESTIGATOR

Westwood Imaging Center & Interventional Radiology Clinic - UCLA, CA, USA

Jay Giri, MD, MPH

PRINCIPAL_INVESTIGATOR

Penn Medicine, Philadelphia, PA, USA

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06519

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

UPHS Penn Health System

Philadelphia, Pennsylvania, 19104

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

Collaborators and Investigators

Sponsor: Inari Medical

Nicolas Meneveau, MD PhD, PRINCIPAL_INVESTIGATOR, Centre Hospitalier Universitaire Hôpital Jean Minjoz, Besançon, France
Stavros Konstantinides, MD PhD, PRINCIPAL_INVESTIGATOR, Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg-University Mainz, Germany
John M Moriarty, MD, PRINCIPAL_INVESTIGATOR, Westwood Imaging Center & Interventional Radiology Clinic - UCLA, CA, USA
Jay Giri, MD, MPH, PRINCIPAL_INVESTIGATOR, Penn Medicine, Philadelphia, PA, USA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-16

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2024-12-16

Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

PE
Pulmonary Embolism
FlowTriever
CDT
Catheter Directed Thrombolysis
Anticoagulation

Additional Relevant MeSH Terms

Pulmonary Embolism
Pulmonary Thromboembolism