Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 10:35 PM
Study NCT ID:
NCT04798261
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2021-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2021-02-26', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Composite of major adverse events', 'timeFrame': '48 hours', 'description': 'A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury'}, {'measure': 'Performance: Change in RV/LV Ratio', 'timeFrame': '48 hours post-procedure', 'description': 'Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available)'}], 'secondaryOutcomes': [{'measure': 'Quality of Life assessed via PEmb-QoL', 'timeFrame': '90 days post-procedure', 'description': 'Self-assessment of PE related complaints and daily living limitations (including work and social)'}, {'measure': 'Quality of Life assessed via EQ-5D-5L', 'timeFrame': '90 days post-procedure', 'description': 'Self-assessment of activities of daily living'}, {'measure': 'Functional outcome assessed NYHA', 'timeFrame': '90 days post-procedure', 'description': 'Physician assessment of heart failure symptoms and activity level'}, {'measure': 'Functional outcome assessed via 6MWT', 'timeFrame': '90 days post-procedure', 'description': 'Walking distance over a 6 minute period to assess functional capacity'}, {'measure': 'Perceived dyspnea assessed via Borg Scale', 'timeFrame': '90 days post-procedure', 'description': 'Category rating scale to measure perceived dyspnea'}, {'measure': 'Incidence of device related SAE(s)', 'timeFrame': '365 days'}, {'measure': 'Any-cause mortality', 'timeFrame': 'Within 30 days'}, {'measure': 'Symptomatic PE recurrence', 'timeFrame': 'Within 30 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '40878986', 'type': 'DERIVED', 'citation': 'Moriarty JM, Schiro BJ, Dohad SY, Tamaddon H, Davis HC, Shavelle DM, Chrysant GS, Iliadis EA, Dexter DJ 2nd, Ciampi Dopazo JJ, Holden A, West FM, Keeling B, Sharp ASP, Weinberg I. Periprocedural Results and Right Ventricular Outcomes of Computer Assisted Vacuum Thrombectomy Treatment of Acute Pulmonary Embolism: Interim Analysis of 300 Patients From the STRIKE-PE Study. J Am Heart Assoc. 2025 Sep 2;14(17):e039975. doi: 10.1161/JAHA.124.039975. Epub 2025 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute pulmonary embolism', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less\n2. RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram\n3. Frontline endovascular treatment with the Indigo Aspiration System per IFU\n4. Patient is ≥ 18 years of age\n5. Informed consent obtained per Institutional Review Board/Ethics Committee requirements\n\nExclusion Criteria:\n\n1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)\n2. Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation\n3. Known serious, uncontrolled sensitivity to radiographic agents\n4. Life expectancy \\< 180 days\n5. Patients on ECMO\n6. Pregnant patients\n7. Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies\n8. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study"}, 'identificationModule': {'nctId': 'NCT04798261', 'briefTitle': 'Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Penumbra Inc.'}, 'officialTitle': 'STRIKE-PE: A Prospective, Multicenter Study of the Indigo™ Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism', 'orgStudyIdInfo': {'id': '18135'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with acute pulmonary embolism', 'interventionNames': ['Device: Indigo Aspiration System']}], 'interventions': [{'name': 'Indigo Aspiration System', 'type': 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