Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-02-09 @ 11:10 PM
Study NCT ID:
NCT06348459
Status:
RECRUITING
Last Update Posted:
2025-04-25
First Post:
2023-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Catheter Intervention in Pulmonary Embolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D013927', 'term': 'Thrombosis'}], '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': 300}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause-death', 'timeFrame': 'during hospital admission (up to day 10)'}], 'secondaryOutcomes': [{'measure': 'all cause-death', 'timeFrame': '48 hours'}, {'measure': 'all cause-death', 'timeFrame': '30 days'}, {'measure': 'all cause-death', 'timeFrame': '2 year'}, {'measure': 'procedural success', 'timeFrame': '48 hours', 'description': 'defined as technical procedure completed without procedural complications or 48-hour death'}, {'measure': 'in-hospital complications', 'timeFrame': 'during hospital admission (up to day 10)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aspiration Thrombectomy', 'Percutaneous Aspiration Thrombectomy', 'Local Thrombolysis'], 'conditions': ['Pulmonary Embolism', 'Pulmonary Embolism Acute Massive', 'Pulmonary Embolism Acute', 'Pulmonary Embolism and Thrombosis', 'Pulmonary Thromboembolisms']}, 'referencesModule': {'references': [{'pmid': '36801109', 'type': 'BACKGROUND', 'citation': 'Ramos-Lopez N, Ferrera C, Luque T, Enriquez-Vazquez D, Mahia-Casado P, Galvan-Herraez L, Pedrajas JM, Salinas P; working group. Impact of a pulmonary embolism response team initiative on hospital mortality of patients with bilateral pulmonary embolism. Med Clin (Barc). 2023 Jun 9;160(11):469-475. doi: 10.1016/j.medcli.2022.12.017. Epub 2023 Feb 16. English, Spanish.'}, {'pmid': '37354942', 'type': 'BACKGROUND', 'citation': 'Salinas P, Vazquez-Alvarez ME, Salvatella N, Ruiz Quevedo V, Velazquez Martin M, Valero E, Rumiz E, Jurado-Roman A, Lozano I, Gallardo F, Amat-Santos IJ, Lorenzo O, Portero Portaz JJ, Huanca M, Nombela-Franco L, Vaquerizo B, Ramallal Martinez R, Maneiro Melon NM, Sanchis J, Berenguer A, Gallardo-Lopez A, Gutierrez-Ibanes E, Mejia-Renteria H, Cordoba-Soriano JG, Jimenez-Mazuecos JM. Catheter-directed therapy for acute pulmonary embolism: results of a multicenter national registry. Rev Esp Cardiol (Engl Ed). 2024 Feb;77(2):138-147. doi: 10.1016/j.rec.2023.06.005. Epub 2023 Jun 22. English, Spanish.'}]}, 'descriptionModule': {'briefSummary': 'Multicenter longitudinal observational ambispective (retrospective cases from 2014 and prospective from 2018 onwards) cohort study. The registry recruits a series of consecutive patients admitted for moderate-high risk or high-risk pulmonary embolism (according to 2019 European Society of Cardiology guidelines) treated invasively. This study aims to describe the acute management of the safety and effectiveness of different percutaneous interventions for acute pulmonary embolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients admitted for moderate-high risk or high-risk PE and treated invasively with any kind of catheter-directed intervention.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (aged 18 years old or older)\n* confirmed diagnosis of acute PE (on computed tomography or echocardiogram plus pulmonary angiography)\n* high-risk PE or intermediate-high risk according to ESC risk stratification in the 2019 guidelines (briefly, elevated cardiac biomarkers \\[troponin or N-terminal pro-B-type natriuretic peptide\\], and right ventricle to left ventricle ratio \\> 0.9 \\[on computed tomography or echocardiogram\\], and PE severity index III to IV or simplified PE severity index=1\n* eligibility for catheter-directed intervention\n\nExclusion Criteria:\n\n* unconfirmed diagnosis of PE\n* undefined risk stratification, and\n* PE with uncertain chronology or beyond seven days of symptom initiation.'}, 'identificationModule': {'nctId': 'NCT06348459', 'acronym': 'RiTEP', 'briefTitle': 'Registry of Catheter Intervention in Pulmonary Embolism', 'organization': {'class': 'OTHER', 'fullName': 'Hospital San Carlos, Madrid'}, 'officialTitle': 'Registry of Catheter Intervention in Pulmonary Embolism', 'orgStudyIdInfo': {'id': '18/010-E'}}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pablo Salinas, MD, PhD', 'role': 'CONTACT', 'email': 'salinas.pablo@gmail.com', 'phone': '+34913303000'}], 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Pablo Salinas, MD, PhD', 'role': 'CONTACT', 'email': 'salinas.pablo@gmail.com', 'phone': '+34 913303000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital San Carlos, Madrid', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Pablo Salinas', 'investigatorAffiliation': 'Hospital San Carlos, Madrid'}}}}