The PERSEVERE Study

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age at enrollment ≥18 years

• Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery

• High-risk class of acute PE

• RV dysfunction, as defined 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 (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards

Locations
United States
Connecticut
Yale University
RECRUITING
New Haven
Florida
Sarasota Memorial Hospital
RECRUITING
Sarasota
Georgia
Emory University
RECRUITING
Atlanta
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
New York
Northwell Health
RECRUITING
Bay Shore
SUNY, The University at Buffalo
RECRUITING
Buffalo
Pennsylvania
UPHS Penn Health System
RECRUITING
Philadelphia
Allegheny General Hospital
RECRUITING
Pittsburgh
Tennessee
HCA Tristar/Centennial
RECRUITING
Nashville
Texas
HCA Medical City Heart & Spine
RECRUITING
Dallas
HCA Methodist Health San Antonio
RECRUITING
San Antonio
Other Locations
France
Besançon University Hospital
RECRUITING
Besançon
Hopital Arnaud de Villeneuve, Montpellier
RECRUITING
Montpellier
CHU Nîmes Caremeau
RECRUITING
Nîmes
Hôpital Européen Georges-Pompidou, Paris
RECRUITING
Paris
Germany
Klinikum Chemnitz
RECRUITING
Chemnitz
Universitätsklinikum Carl Gustav Carus an der TU Dresden
RECRUITING
Dresden
Universitätsmedizin Mainz
RECRUITING
Mainz
Munich LMU
RECRUITING
München
Universitätsklinik Regensburg
RECRUITING
Regensburg
Spain
Hospital Universitari Vall d'Hebron, Barcelona
RECRUITING
Barcelona
Hospital Universitario La Paz Madrid
RECRUITING
Madrid
Switzerland
University Hospital Basel
RECRUITING
Basel
United Kingdom
Royal Free Hospital London
RECRUITING
London
Contact Information
Primary
Tine Devolder
tine.devolder@inarimedical.com
+32 476 53 88 05
Backup
Jen Foss
jenifer.foss@stryker.com
978-587-6598
Time Frame
Start Date: 2024-12-16
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 200
Treatments
Active_comparator: FlowTriever
Active_comparator: Standard of Care
Related Therapeutic Areas
Sponsors
Leads: Inari Medical

This content was sourced from clinicaltrials.gov