Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-01-07 @ 8:40 PM
Study NCT ID:
NCT06588634
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2024-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The PERSEVERE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2024-09-06', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite clinical endpoint of the following adjudicated events:', 'timeFrame': 'The earlier of initial hospital discharge or 7 days after randomization', 'description': '1. All-cause mortality\n2. Cardiac arrest\n3. Bailout to an alternative therapeutic strategy\n4. Major bleeding\n5. ECMO life support'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit'}, {'measure': 'Cardiac arrest', 'timeFrame': 'At the earlier of initial hospital discharge or 7 days post randomization'}, {'measure': 'Bailout to an alternative therapeutic strategy', 'timeFrame': 'At the earlier of initial hospital discharge or 7 days post randomization'}, {'measure': 'Major bleeding', 'timeFrame': 'At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit'}, {'measure': 'ECMO life support', 'timeFrame': '7 days post-randomization'}, {'measure': 'PE-related mortality', 'timeFrame': '3 months'}, {'measure': 'All-cause and PE-related readmissions', 'timeFrame': '30 days and 90 days'}, {'measure': 'Days alive outside hospital', 'timeFrame': '90 days'}, {'measure': 'PE-related quality of life, by PEmb-QoL', 'timeFrame': '3 months'}, {'measure': 'General health-related quality of life, by EQ-5D-5L', 'timeFrame': '3 months'}, {'measure': 'Post-PE Impairment diagnosis', 'timeFrame': '3 months'}, {'measure': 'Change in the RV/LV diastolic diameter ratio (RV/LV) as measured by echocardiography from baseline', 'timeFrame': '72 hours'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['PE', 'Pulmonary Embolism', 'FlowTriever', 'CDT', 'Catheter Directed Thrombolysis', 'Anticoagulation'], 'conditions': ['Pulmonary Embolism', 'Pulmonary Thromboembolism']}, 'descriptionModule': {'briefSummary': 'Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age at enrollment ≥18 years\n2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery\n3. High-risk class of acute PE\n4. RV dysfunction, as defined RV/LV ratio ≥1.0\n5. 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\n\nExclusion Criteria:\n\n1. Prolonged cardiac arrest with loss of consciousness associated with neurological deficit.\n2. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention\n3. Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH\n4. Recent stroke (\\<14 days)\n5. Recent cranial or spinal surgery (\\<14 days)\n6. Life-threatening active bleeding or hemorrhage into a critical area\n7. Known intracranial tumor\n8. End-stage medical condition with life expectancy \\<3 months (irrespective of the severity of acute PE), as determined by the Investigator\n9. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated\n10. Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT)\n11. Current participation in another drug or device study that may interfere with the conduct of this trial\n12. Ventricular arrhythmias refractory to treatment at the time of enrollment\n13. 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\n14. Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions\n15. Subject was previously enrolled in this study\n16. 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"}, 'identificationModule': {'nctId': 'NCT06588634', 'briefTitle': 'The PERSEVERE Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inari Medical'}, 'officialTitle': 'The PERSEVERE Study', 'orgStudyIdInfo': {'id': '24-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FlowTriever', 'interventionNames': ['Device: FlowTriever System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'interventionNames': ['Procedure: Standard of Care']}], 'interventions': [{'name': 'FlowTriever System', 'type': 'DEVICE', 'description': 'Mechanical thrombectomy for pulmonary embolism', 'armGroupLabels': ['FlowTriever']}, {'name': 'Standard of Care', 'type': 'PROCEDURE', 'description': 'Standard of care treatment for pulmonary embolism', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Moore, MD', 'role': 'CONTACT'}], 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Juan Camacho, MD', 'role': 'CONTACT'}], 'facility': 'Sarasota Memorial Hospital', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wissam Jaber, MD', 'role': 'CONTACT'}], 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 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'CONTACT'}], 'facility': 'HCA Methodist Health San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '25030', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas Meneveau, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Besançon University Hospital', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Francoise Roubille, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Arnaud de Villeneuve, Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benoit Lattuca, MD, PhD', 'role': 'CONTACT'}], 'facility': 'CHU Nîmes Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Sanchez, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Hôpital Européen Georges-Pompidou, Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Chemnitz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Karim Ibrahim, MD', 'role': 'CONTACT'}], 'facility': 'Klinikum Chemnitz', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ralf-Thorsten Hoffmann, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Carl Gustav Carus an der TU Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '55131', 'city': 'Mainz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stavros Konstantinides, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Universitätsmedizin Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Konstantin Stark, MD', 'role': 'CONTACT'}], 'facility': 'Munich LMU', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Regensburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan Stadler, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinik Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Carlos Ruiz, MD, PhD', 'role': 'CONTACT'}], 'facility': "Hospital Universitari Vall d'Hebron, Barcelona", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28046', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raul Moreno, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario La Paz Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Gregor Leibundgut, MD', 'role': 'CONTACT'}], 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Tushar Kotecha, MBChB, PhD', 'role': 'CONTACT'}], 'facility': 'Royal Free Hospital London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Tine Devolder', 'role': 'CONTACT', 'email': 'tine.devolder@inarimedical.com', 'phone': '+32 476 53 88 05'}, {'name': 'Jen Foss', 'role': 'CONTACT', 'email': 'jenifer.foss@stryker.com', 'phone': '978-587-6598'}], 'overallOfficials': [{'name': 'Nicolas Meneveau, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Hôpital Jean Minjoz, Besançon, France'}, {'name': 'Stavros Konstantinides, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg-University Mainz, Germany'}, {'name': 'John M Moriarty, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Westwood Imaging Center & Interventional Radiology Clinic - UCLA, CA, USA'}, {'name': 'Jay Giri, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn Medicine, Philadelphia, PA, USA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inari Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}