Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-02 @ 8:18 AM
Study NCT ID:
NCT06631157
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2024-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Essential Pro Study ( rEPIC04E-HK )
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': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2024-10-02', 'studyFirstSubmitQcDate': '2024-10-04', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', '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). 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 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', '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': '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': 'Single center, 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': 'This study intends to analyze:\n\n* Device effectiveness (in its individual use, technical performance) and procedural effectiveness (technical outcome at the end of lesion treatment with the device under study and any other device being used).\n* Device safety (in its individual use, technical performance) and procedural safety (technical outcome at the end of lesion treatment with the device under study and any other device being used).\n* Clinical outcomes at the end of the procedure and during the specified follow-up period for each device. The follow-up timeframe is established based on the conditions of use and type of device being used, according to the requirements established by the relevant Notified Body.'}, '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': 'NCT06631157', 'acronym': 'rEPIC04E-HK', 'briefTitle': 'Essential Pro Study ( rEPIC04E-HK )', 'organization': {'class': 'OTHER', 'fullName': 'Fundación EPIC'}, 'officialTitle': 'Essential Pro Post-Market Clinical Follow-up Study', 'orgStudyIdInfo': {'id': 'rEPIC04E-HK- Pro Study-HK'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary Artery Disease (CAD)', 'interventionNames': ['Device: Essential pro']}], 'interventions': [{'name': 'Essential pro', 'type': 'DEVICE', 'description': 'Patients in whom treatment with (Essential Pro) has been attempted', 'armGroupLabels': ['Coronary Artery Disease (CAD)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lai Chi Kok', 'status': 'RECRUITING', 'country': 'Hong Kong', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 22.3369, 'lon': 114.14031}}], 'centralContacts': [{'name': 'FUNDACION EPIC', 'role': 'CONTACT', 'email': 'iepic@fundacionepic.org', 'phone': '0034987225638'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación EPIC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}