Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT04533633
Status:
UNKNOWN
Last Update Posted:
2020-09-01
First Post:
2020-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
German Epicardial Collateral CTO Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'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': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-29', 'studyFirstSubmitDate': '2020-08-23', 'studyFirstSubmitQcDate': '2020-08-26', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of technically successful retrograde CTO-PCI using epicaridal collaterals', 'timeFrame': '30 days', 'description': 'defined as the rate of successful CTO-PCI with reestablished antegrade coronary flow (thrombolysis in myocardial infarction (TIMI) flow III) with less than residual stenosis of 50%.'}], 'secondaryOutcomes': [{'measure': 'Rate of clinically successful retrograde CTO-PCI using epicaridal collaterals', 'timeFrame': '30 days', 'description': 'Clinical success is defined as the rate of successful CTO-PCI by technical success without MACCE and without major periprocedural complications, including pericardial tamponade and contrast induced dialysis.'}, {'measure': 'Rate of failed retrograde CTO-PCI using epicaridal collaterals', 'timeFrame': '30 days', 'description': 'is defined as the rate of CTO-PCI without technical success defined as residual stenosis \\>50% (by visual estimation) and TIMI flow grade \\<3 after CTO-PCI.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Chronic Total Occlusion', 'Percutaneous Coronary Intervention']}, 'descriptionModule': {'briefSummary': 'The EPIC registry is an observational multicentre registry evaluating the technical feasibility of retrograde CTO-PCI using epicardial collateral connections. It will evaluate the frequency, effectiveness, safety and outcomes of patients who underwent CTO-PCI using this approach. The EPIC registry retrieves data from CTO centres across Germany.', 'detailedDescription': 'The EPIC registry is the first German-wide observational multicentre registry evaluating the technical feasibility, clinical success and safety of retrograde CTO-PCI using epicardial collateral connections. The EPIC registry retrieves data from CTO centres across Germany. All patients will be followed-up to 30 days after inclusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'EPIC will observationally evaluate all patients undergoing retrograde CTO-PCI using epicardial collateral connections during daily clinical practice from German CTO centres.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing retrograde CTO-PCI using epicardial collateral connections during daily clinical practice.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT04533633', 'acronym': 'EPIC', 'briefTitle': 'German Epicardial Collateral CTO Registry', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsmedizin Mannheim'}, 'officialTitle': 'German Multicentre Registry to Evaluate the Technical Feasibilty of Epicardial Collateral Connections in CTO PCI', 'orgStudyIdInfo': {'id': '2017-838R-MA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Retrograde Percutaneous Coronary Intervention of Chronic Total Occlusion', 'type': 'PROCEDURE', 'description': 'Retrograde CTO-PCI using epicardial collateral connections'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76149', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Behnes', 'role': 'CONTACT', 'email': 'michael.behnes@umm.de', 'phone': '+496213836239'}], 'facility': 'University Medical Centre Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'centralContacts': [{'name': 'Michael Behnes, Prof. Dr.', 'role': 'CONTACT', 'email': 'michael.behnes@umm.de', 'phone': '+49 621 383 6239'}, {'name': 'Kambis Mashayekhi, Dr.', 'role': 'CONTACT', 'email': 'Kambis.Mashayekhi@universitaets-herzzentrum.de', 'phone': '+49 7633 402 2100'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Heart Center Freiburg - Bad Krozingen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Behnes', 'investigatorAffiliation': 'Universitätsmedizin Mannheim'}}}}