The PERSEVERE Study

Обзор

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

Вмешательства

• Устройство FlowTriever System
  Mechanical thrombectomy for pulmonary embolism
• Процедура Standard of Care
  Standard of care treatment for pulmonary embolism

Первичные конечные точки

• Composite clinical endpoint of the following adjudicated events: [Срок оценки: The earlier of initial hospital discharge or 7 days after randomization]

Вторичные конечные точки (12)

• All-cause mortality [Срок оценки: At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit]
• Cardiac arrest [Срок оценки: At the earlier of initial hospital discharge or 7 days post randomization]
• Bailout to an alternative therapeutic strategy [Срок оценки: At the earlier of initial hospital discharge or 7 days post randomization]
• Major bleeding [Срок оценки: At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit]
• ECMO life support [Срок оценки: 7 days post-randomization]
• PE-related mortality [Срок оценки: 3 months]
• All-cause and PE-related readmissions [Срок оценки: 30 days and 90 days]
• Days alive outside hospital [Срок оценки: 90 days]
• PE-related quality of life, by PEmb-QoL [Срок оценки: 3 months]
• General health-related quality of life, by EQ-5D-5L [Срок оценки: 3 months]
• Post-PE Impairment diagnosis [Срок оценки: 3 months]
• Change in the RV/LV diastolic diameter ratio (RV/LV) as measured by echocardiography from baseline [Срок оценки: 72 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Prolonged cardiac arrest with loss of consciousness associated with neurological deficit.
• Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention
• Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH
• Recent stroke (<14 days)
• Recent cranial or spinal surgery (<14 days)
• Life-threatening active bleeding or hemorrhage into a critical area
• Known intracranial tumor
• End-stage medical condition with life expectancy <3 months (irrespective of the severity of acute PE), as determined by the Investigator
• Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
• Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT)
• Current participation in another drug or device study that may interfere with the conduct of this trial
• Ventricular arrhythmias refractory to treatment at the time of enrollment
• 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
• Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions
• Subject was previously enrolled in this study
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 15 центров

• Yale University — New Haven
• AdventHealth Orlando — Orlando
• Orlando Health Regional Medical Center — Orlando
• Sarasota Memorial Hospital — Sarasota
• Emory University — Atlanta
• University of Mississippi Medical Center — Jackson
• Northwell Health — Bay Shore
• SUNY, The University at Buffalo — Buffalo
• … и ещё 7 центров

Германия · 5 центров

• Klinikum Chemnitz — Chemnitz
• Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden
• Universitätsmedizin Mainz — Mainz
• Munich LMU — München
• Universitätsklinik Regensburg — Regensburg

Франция · 4 центра

• Besançon University Hospital — Besançon
• Hopital Arnaud de Villeneuve, Montpellier — Montpellier
• CHU Nîmes Caremeau — Nîmes
• Hôpital Européen Georges-Pompidou, Paris — Paris

Испания · 2 центра

• Hospital Universitari Vall d'Hebron, Barcelona — Barcelona
• Hospital Universitario La Paz Madrid — Madrid

Швейцария · 1 центр

• University Hospital Basel — Basel

Великобритания · 1 центр

• Royal Free Hospital London — London

Публикации

• Chopard R, Hobohm L, Barco S, Bangalore S, Giri J, Mahfoud F, Moriarty J, Rosenkranz S, Sharp A, Thiele H, Toma C, Tapson VF, Markovitz CD, Rosenberg SP, Konstantinides S, Meneveau N. Large-bore mechanical thrombectomy vs standard of care for acute high-risk pulmonary embolism: Rationale and design of the PERSEVERE randomized controlled trial. Am Heart J. 2026 Apr;294:107331. doi: 10.1016/j.ahj.20 PMID 41453591

Идентификаторы

NCT: NCT06588634 · 24-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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