Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT06971718
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coronary Bifurcations With Ischaemia and Flow Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiological assessment', 'timeFrame': '3-9 months', 'description': 'Physiological assessment measuring:\n\n* FFR (Main vessel and side branch)\n* Wall sheer stress'}, {'measure': 'OCT derived anatomical measure', 'timeFrame': '3-9 months', 'description': 'Mean lumen area main vessel and mean lumen area side branch'}], 'secondaryOutcomes': [{'measure': 'Late lumen loss', 'timeFrame': '3-9 months', 'description': 'Angiographic assessment of late lumen loss in main vessel and side branch'}, {'measure': 'Device oriented clinical endpoints', 'timeFrame': '3-9 months', 'description': 'Composite of:\n\n* Cardiovascular death\n* Device failure related MI\n* Device failure related ischaemia\n* Target bifurcation revascularisation'}, {'measure': 'Patient focused endpoint: Angina', 'timeFrame': '12 months', 'description': 'Seattle angina questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug coated balloons', 'Coronary bifurcation lesions', 'Computational flow dynamics'], 'conditions': ['Coronary Bifurcation Lesions']}, 'descriptionModule': {'briefSummary': 'The coronary arteries are blood vessels that provide oxygen rich blood to the muscle of the heart. If these vessels become narrowed or blocked, this can lead to chest pain (called angina) or heart attacks. Narrowings are usually treated using metal scaffolds called drug eluting stents. However, in one in five cases where the narrowing occurs at a branching point, treating it with stents is more challenging and can cause complications. A possible alternative treatment is using a special type of balloon called a drug-coated balloon. This balloon is inflated in the blood vessel and releases medicine to help widen the blood vessel and the procedure is completed without leaving any metallic scaffold behind.\n\nThis study aims to compare drug coated balloons with drug eluting stents to see which treatment works better for narrowing that occurs at branching points. We will used advanced imaging techniques to create computer models of blood flow in the vessels, and we will follow up with patients over tie to see how well the treatments work.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient with coronary bifurcation lesion who fulfills the inclusion criteria and is not precluded by the exclusion criteria is suitable for recruitment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or over\n* Any bifurcation lesion amenable to a provisional main vessel treatment strategy\n* A main vessel diameter of 2.5mm or more and side branch diameter of \\>2mm\n* Any patient with stable angina, silent ischaemia, unstable angina or NSTEMI\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Cardiogenic shock\n* LVEF \\<30%\n* STEMI (as unable to give informed consent)\n* eGFR \\<30\n* Severe asthma contraindicating use of adenosine\n* High degree AV block on 12 lead ECG precluding the use of adenosine\n* Pregnancy\n* Inability to consent\n* Left main stem coronary bifurcation lesions'}, 'identificationModule': {'nctId': 'NCT06971718', 'briefTitle': 'Coronary Bifurcations With Ischaemia and Flow Assessment', 'organization': {'class': 'OTHER', 'fullName': 'University of East Anglia'}, 'officialTitle': 'Drug Coated Balloons in Coronary Bifurcation Lesions. A Feasibility Study Looking at Computational Flow Dynamics, Ischaemic and Anatomical Changes to the Bifurcation', 'orgStudyIdInfo': {'id': '325142'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Drug eluted stent', 'interventionNames': ['Diagnostic Test: Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment']}, {'label': 'Drug coated balloon', 'interventionNames': ['Diagnostic Test: Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment']}], 'interventions': [{'name': 'Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Optical coherence tomography'], 'description': 'OCT and pressure wire of the main vessel and side branch of the bifurcation are undertaken prior to and after treating the lesion and at 3-9 month follow up.', 'armGroupLabels': ['Drug coated balloon', 'Drug eluted stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NR47TJ', 'city': 'Norwich', 'state': 'Norfolk', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Natasha Corballis', 'role': 'CONTACT', 'email': 'natasha.corballis@nnuh.nhs.uk', 'phone': '01603286286'}], 'facility': 'Norwich Medical School, University of East Anglia', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}], 'centralContacts': [{'name': 'Natasha Corballis, MBBS, MRCP (UK), MSc', 'role': 'CONTACT', 'email': 'natasha.corballis@nnuh.nhs.uk', 'phone': '01603286286'}], 'overallOfficials': [{'name': 'Vassilios S Vassiliou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwich Medical School'}, {'name': 'Simon C Eccleshall', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of East Anglia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norfolk and Norwich University Hospitals NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}