Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-21 @ 6:49 PM
Study NCT ID:
NCT05292105
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2022-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NC Xperience PMCF Study( rEPIC04B)
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': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2022-03-14', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Endpoint. Freedom from Target Lesion Failure', 'timeFrame': '7 days', 'description': 'Freedom from composite of cardiac death, myocardial infarction (MI) and Target Lesion Revascularization (TLR)'}], 'secondaryOutcomes': [{'measure': 'Efficacy Endpoint. freedom from Target Lesion Failure', 'timeFrame': '7 days', 'description': 'Freedom from composite of cardiac death, myocardial infarction (MI)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)', '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': '12772236', 'type': 'BACKGROUND', 'citation': 'Brodie BR, Cooper C, Jones M, Fitzgerald P, Cummins F; Postdilatation Clinical Compartative Study (POSTIT) Investigators. Is adjunctive balloon postdilatation necessary after coronary stent deployment? Final results from the POSTIT trial. Catheter Cardiovasc Interv. 2003 Jun;59(2):184-92. doi: 10.1002/ccd.10474.'}, {'pmid': '29450169', 'type': 'BACKGROUND', 'citation': "Chandrasekhar J, Allada C, O'Connor S, Rahman M, Shadbolt B, Farshid A. Efficacy of non-compliant balloon post-dilation in optimization of contemporary stents: A digital stent enhancement study. Int J Cardiol Heart Vessel. 2014 Mar 19;3:43-48. doi: 10.1016/j.ijchv.2014.03.006. eCollection 2014 Jun."}, {'pmid': '23703842', 'type': 'BACKGROUND', 'citation': 'Pasceri V, Pelliccia F, Pristipino C, Roncella A, Irini D, Varveri A, Bisciglia A, Speciale G. Clinical effects of routine postdilatation of drug-eluting stents. Catheter Cardiovasc Interv. 2014 May 1;83(6):898-904. doi: 10.1002/ccd.24999. Epub 2013 Dec 18.'}, {'pmid': '25480993', 'type': 'BACKGROUND', 'citation': "Rana O, Shah NC, Wilson S, Swallow R, O'Kane P, Levy T. The impact of routine and intravascular ultrasound-guided high-pressure postdilatation after drug-eluting stent deployment: the STent OPtimization (STOP) study. J Invasive Cardiol. 2014 Dec;26(12):640-6."}, {'pmid': '25733175', 'type': 'BACKGROUND', 'citation': 'Kim BG, Cho SW, Kim DH, Kim JH, Byun YS, Goh CW, Rhee KJ, Lee BK, Kim BO. Stent length is a contributing factor of suboptimal stent expansion in drug-eluting stents. Kardiol Pol. 2015;73(8):598-605. doi: 10.5603/KP.a2015.0034. Epub 2015 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of NC Xperience to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with NC Xperience .', '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 NC Xperience 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 NC Xperience according to routine hospital practice and following instructions for use', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient treated with NC Xperience 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': 'NCT05292105', 'acronym': 'rEPIC04B', 'briefTitle': 'NC Xperience PMCF Study( rEPIC04B)', 'organization': {'class': 'OTHER', 'fullName': 'Fundación EPIC'}, 'officialTitle': 'NC Xperience Post-Market Clinical Follow-up Study', 'orgStudyIdInfo': {'id': 'NC Xperience PMCF Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary Artery Disease (CAD)', 'interventionNames': ['Device: NC Xperience']}], 'interventions': [{'name': 'NC Xperience', 'type': 'DEVICE', 'description': 'Coronary dilatation balloon catheter (non compliant)', 'armGroupLabels': ['Coronary Artery Disease (CAD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28905', 'city': 'Getafe', 'country': 'Spain', 'facility': 'Hospital Universitario de Getafe', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación EPIC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}