Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-01 @ 9:19 PM
Study NCT ID:
NCT05292092
Status:
RECRUITING
Last Update Posted:
2025-06-24
First Post:
2022-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Essential Pro PMCF Study ( rEPIC04E )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 176}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-21', 'studyFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2022-03-14', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Endpoint. Freedom from Target Lesion Failure', 'timeFrame': '12 months', 'description': 'Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR).'}], 'secondaryOutcomes': [{'measure': 'Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)', 'timeFrame': '12 months', 'description': 'Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).'}, {'measure': 'Freedom from Balloon rupture', 'timeFrame': 'During percutaneous coronary intervention (PCI)', 'description': 'Freedom from Balloon rupture'}, {'measure': 'Freedom from Hypotube rupture', 'timeFrame': 'During PCI', 'description': 'Freedom from Hypotube rupture'}, {'measure': 'Freedom from Complicated withdrawal', 'timeFrame': 'During PCI', 'description': 'Freedom from Complicated withdrawal'}, {'measure': 'Freedom from Coronary perforation', 'timeFrame': 'During PCI', 'description': 'Freedom from Coronary perforation'}, {'measure': 'Freedom from Coronary dissection >C', 'timeFrame': 'During PCI', 'description': 'Freedom from Coronary dissection \\>C'}, {'measure': 'Freedom from No reflow', 'timeFrame': 'During PCI', 'description': 'Freedom from No reflow'}, {'measure': 'Freedom from Coronary thrombosis', 'timeFrame': 'During PCI', 'description': 'Freedom from Coronary thrombosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MDR (Medical Device Regulations)', 'PMCF (Post-Market Clinical Follow-up)', 'Paclitaxel eluting coronary balloon dilatation catheter'], 'conditions': ['Coronary Artery Disease (CAD)', 'Ischemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '74678', 'type': 'BACKGROUND', 'citation': 'Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available.'}, {'pmid': '30170854', 'type': 'BACKGROUND', 'citation': 'Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.'}, {'pmid': '33953973', 'type': 'BACKGROUND', 'citation': 'Wu X, Li L, He L. Drug-Coated Balloon versus Drug-Eluting Stent in Patients with Small-Vessel Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials. Cardiol Res Pract. 2021 Apr 13;2021:1647635. doi: 10.1155/2021/1647635. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Essential Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Essential Pro.', 'detailedDescription': 'The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Essential Pro in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with Essential Pro according to routine hospital practice and following instructions for use', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient treated with Essential Pro according to routine hospital practice and following instructions for use\n* Informed consent signed\n\nExclusion Criteria:\n\n• Not meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT05292092', 'acronym': 'rEPIC04E', 'briefTitle': 'Essential Pro PMCF Study ( rEPIC04E )', 'organization': {'class': 'OTHER', 'fullName': 'Fundación EPIC'}, 'officialTitle': 'Essential Pro Post-Market Clinical Follow-up Study', 'orgStudyIdInfo': {'id': 'Essential Pro PMCF Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary Artery Disease (CAD)', 'interventionNames': ['Drug: Essential pro']}], 'interventions': [{'name': 'Essential pro', 'type': 'DRUG', 'description': 'Patients in whom treatment with (Essential Pro) has been attempted', 'armGroupLabels': ['Coronary Artery Disease (CAD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11207', 'city': 'Algeciras', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Punta de Europa', 'geoPoint': {'lat': 36.13326, 'lon': -5.45051}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '11407', 'city': 'Jerez de la Frontera', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Jerez de la Frontera', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'zip': '24080', 'city': 'León', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Leon', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '29010', 'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Regional de Malaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '11510', 'city': 'Puerto Real', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Puerto Real', 'geoPoint': {'lat': 36.52819, 'lon': -6.19011}}, {'zip': '39008', 'city': 'Santander', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}], 'centralContacts': [{'name': 'FUNDACION EPIC', 'role': 'CONTACT', 'email': 'iepic@fundacionepic.org', 'phone': '987225638'}, {'name': 'FUNDACION EPIC', 'role': 'CONTACT', 'email': 'admin@fundacionepic.org', 'phone': '987225638'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación EPIC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}