Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT03538067
Status:
UNKNOWN
Last Update Posted:
2018-05-25
First Post:
2017-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Balloon Inflation and Plaque Morphology in Revascularisation (BURST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Venous blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-15', 'studyFirstSubmitDate': '2017-07-31', 'studyFirstSubmitQcDate': '2018-05-15', 'lastUpdatePostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-stent minimal luminal area (MLA, mm2)', 'timeFrame': 'Immediate - peri-procedurally', 'description': 'As measured by intravascular ultrasound'}], 'secondaryOutcomes': [{'measure': 'Plaque characteristics', 'timeFrame': 'Immediate - peri-procedural', 'description': 'As determined by virtual histology intravascular ultrasound (VH-IVUS)'}, {'measure': 'Stent deployment', 'timeFrame': 'Immediate - peri-procedural', 'description': 'Determined by intravascular ultrasound (IVUS - MUSIC Criteria)'}, {'measure': 'Peri-procedural myocardial infarction', 'timeFrame': 'Immediate - peri-procedural', 'description': 'In accordance with academic research consortium (ARC) definition'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['percutaneous coronary intervention', 'stent apposition', 'stent deployment', 'stent expansion', 'intravascular ultrasound'], 'conditions': ['Coronary Artery Disease', 'Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'This study will look at the effects of standardised balloon inflation times, pressure and balloon types and atherosclerotic plaque morphology on the procedural results of percutaneous coronary intervention (PCI).', 'detailedDescription': 'Patients presenting with symptoms of coronary artery disease (e.g. chest pain - angina) are often treated with stents (referred to as percutaneous coronary intervention, PCI). Stents treat the cause of symptoms by improving blood flow to the heart muscle through expanding a narrowed, or diseased segment within a coronary artery. The procedure involves the inflation of a balloon to expand the stent inside the artery. As part of standard clinical care multiple balloon inflations are required during the procedure. Deficiencies in the expansion of the stent at the time of the procedure are associated serious complications such as stent blockages or re-narrowing of the artery, either of which may not occur until much later.\n\nImprovements to the technique of stent expansion are therefore highly desirable to improve outcomes for patients. A number of factors are thought to influence the success of the procedure, including: the type of balloon used to inflate the stent, the pressure used and the duration of balloon inflation. Another important factor may be the mechanical properties of the narrowed segment of the artery (plaque) and how they interact with the stent. At present however, there is no consensus view and the practise of individual cardiologists consequently remains highly variable.\n\nThe aim of this study is better characterise relationship between pressure and duration of balloon inflation, type of balloon used and plaque properties during stent procedures using state-of-the-art imaging. Although assessment of each of these factors by a cardiologist is already included as part of standard care, our research protocol will focus the analysis into a systematic framework to allow conclusions to be drawn. The findings will used better inform cardiologists of the technical modifications that can help improve stenting procedures and translate to better outcomes for patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with symptomatic coronary artery disease (stable angina, non-ST elevation acute coronary syndromes) already referred for coronary intervention will be prospectively enrolled sequentially as they attend the St Thomas' Cardiac Catheterisation Laboratories.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic coronary artery disease (stable angina, non-ST elevation acute coronary syndromes) undergoing percutaneous coronary intervention with intracoronary ultrasound (IVUS) guidance\n* Patients \\> 18 years\n* De novo coronary stenoses in native coronary arteries\n* Written informed consent\n\nExclusion Criteria:\n\n* ST-elevation acute coronary syndrome\n* Haemodynamic instability\n* Cardiogenic shock\n* Severe renal dysfunction (eGFR \\< 30 ml/min/1.73m2)\n* In-stent restenosis\n* Chronic total occlusions\n* Saphenous vein and arterial bypass grafts\n* Patients who are currently enrolled in any other study where involvement in this study would involve significant deviation from either protocol'}, 'identificationModule': {'nctId': 'NCT03538067', 'acronym': 'BURST', 'briefTitle': 'Balloon Inflation and Plaque Morphology in Revascularisation (BURST)', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Influence of Balloon Inflation Techniques and Plaque Characteristics on Stent Under-expansion in Percutaneous RevasculariSaTion (BURST)', 'orgStudyIdInfo': {'id': '212423'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Paired sample group', 'description': 'Patients with symptomatic coronary artery disease (stable, NSTEACS) undergoing planned percutaneous coronary intervention with intravascular ultrasound (IVUS) guidance', 'interventionNames': ['Procedure: Percutaneous coronary intervention (PCI)']}], 'interventions': [{'name': 'Percutaneous coronary intervention (PCI)', 'type': 'PROCEDURE', 'description': 'Patients will undergo PCI with intravascular ultrasound (IVUS) as part of standard clinical care in accordance with operator discretion. The research protocol will be observational - using IVUS to determine the effects of balloon inflation time, balloon inflation pressure, balloon type, atherosclerotic plaque morphology on stent expansion (minimal luminal area, MLA)', 'armGroupLabels': ['Paired sample group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Christopher J Allen, MBChB, MRCP', 'role': 'CONTACT', 'email': 'christopher.allen@kcl.ac.uk', 'phone': '+44 (0)2071887184'}], 'overallOfficials': [{'name': 'Simon Redwood, MD FRCP FACC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London, Guy's and St Thomas' Hospital, London"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'collaborators': [{'name': "King's College London", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}