Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT03474432
Status:
TERMINATED
Last Update Posted:
2024-05-17
First Post:
2018-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'miv@uic.edu', 'phone': '312-996-6730', 'title': 'Dr. Mladen Vidovich, study PI', 'organization': 'Jesse Brown VAMC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected at 1, 3, 6 and 12 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Optical Coherence Tomography', 'description': 'Patients who have undergone clinically-indicated PCI of LM where OCT was performed as part of the routine index procedure will be approached for the study and enrolled if eligible.\n\nOptical Coherence Tomography: OCT will be performed with the St. Jude OCT system.\n\nDetection of metallic stent struts will be performed automatically with manual adjustments made as necessary. Stent area tracings will be automatically performed by interpolated contours connecting the center point of the luminal surface of each detected metallic strut. Stent expansion will be determined as the minimum stent area divided by the average reference lumen area and presented as a percentage. Neo-intimal hyperplasia (NIH) area will be determined in follow-up examinations as the area between the stent and lumen contours. Incomplete stent apposition (ISA) area will be determined as the area between the stent contour and the lumen contour at the site of malapposed struts, in a region not overlying a side branch ostium.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Urinary Tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Stent mallaposition needing angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}, {'units': 'Stents', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Optical Coherence Tomography', 'description': 'Patients who have undergone clinically-indicated PCI of LM where OCT was performed as part of the routine index procedure will be approached for the study and enrolled if eligible.\n\nOptical Coherence Tomography: OCT will be performed with the St. Jude OCT system.\n\nDetection of metallic stent struts will be performed automatically with manual adjustments made as necessary. Stent area tracings will be automatically performed by interpolated contours connecting the center point of the luminal surface of each detected metallic strut. Stent expansion will be determined as the minimum stent area divided by the average reference lumen area and presented as a percentage. Neo-intimal hyperplasia (NIH) area will be determined in follow-up examinations as the area between the stent and lumen contours. Incomplete stent apposition (ISA) area will be determined as the area between the stent contour and the lumen contour at the site of malapposed struts, in a region not overlying a side branch ostium.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '95.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 Months', 'description': 'The stents from 6 participants were analyzed for strut coverage, which is specifically defined as Percentage of Uncovered Stent Struts. The Percentage of Uncovered Stent Struts is the number of struts without distinct overlying tissue, in which the luminal reflection of the strut surface is directly interfacing with the lumen, divided by total number of analyzable struts.', 'unitOfMeasure': 'Percentage of Uncovered Stent Struts', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Stents', 'denomUnitsSelected': 'Stents', 'populationDescription': '6 participants had stents analyzed at 3 months.'}, {'type': 'SECONDARY', 'title': 'The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}, {'units': 'Stents', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Optical Coherence Tomography', 'description': "Patients who have undergone clinically-indicated PCI of LM where OCT was performed as part of the routine index procedure will be approached for the study and enrolled if eligible.\n\nOptical Coherence Tomography: OCT will be performed with the St. Jude OCT system.\n\nDetection of metallic stent struts will be performed automatically with manual adjustments made as necessary. Stent area tracings will be automatically performed by interpolated contours connecting the center point of the luminal surface of each detected metallic strut. Stent expansion will be determined as the minimum stent area divided by the average reference lumen area and presented as a percentage. Neo-intimal hyperplasia (NIH) area will be determined in follow-up examinations as the area between the stent and lumen contours. Incomplete stent apposition (ISA) area will be determined as the area between the stent contour and the lumen contour at the site of malapposed struts, in a region not overlying a side branch ostium.\n\nBetween July 11, 2018 and December 31, 2019, 12 participants with 13 treated lesions were enrolled. Two patients were lost to follow-up, two patients withdrew consent due to living too remotely to follow up, one patient's imaging data was unreadable upon analysis, and one patient was withdrawn by an investigator prior to follow-up for worsening renal function. Six participants with 7 treated lesions had at least 3-month follow-up data and 2 patients had 12-month data available."}], 'classes': [{'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000', 'lowerLimit': '93.6', 'upperLimit': '95.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 month', 'description': 'The stents from 2 participants were analyzed for strut coverage, which is specifically defined as Percentage of Uncovered Stent Struts. The Percentage of Uncovered Stent Struts is the number of struts without distinct overlying tissue, in which the luminal reflection of the strut surface is directly interfacing with the lumen, divided by total number of analyzable struts.', 'unitOfMeasure': 'Percentage of Uncovered Stent Struts', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Stents', 'denomUnitsSelected': 'Stents', 'populationDescription': '2 participants had data analyzed at 12 months.'}, {'type': 'SECONDARY', 'title': '3-month Persistent Stent Malapposition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Optical Coherence Tomography', 'description': 'Patients who have undergone clinically-indicated PCI of LM where OCT was performed as part of the routine index procedure will be approached for the study and enrolled if eligible.\n\nOptical Coherence Tomography: OCT will be performed with the St. Jude OCT system.\n\nDetection of metallic stent struts will be performed automatically with manual adjustments made as necessary. Stent area tracings will be automatically performed by interpolated contours connecting the center point of the luminal surface of each detected metallic strut. Stent expansion will be determined as the minimum stent area divided by the average reference lumen area and presented as a percentage. Neo-intimal hyperplasia (NIH) area will be determined in follow-up examinations as the area between the stent and lumen contours. Incomplete stent apposition (ISA) area will be determined as the area between the stent contour and the lumen contour at the site of malapposed struts, in a region not overlying a side branch ostium.\n\nPercent neointimal volume was mild with a median of 3.5% (IQR 2.3%-8.2%) at 3 months and 14.5% (IQR 13.5%-15.5%) at 12 months. The lumen was well preserved, and the median minimum lumen area (MLA) in the LM measured 9.97 mm2 (IQR 9.11 mm2 -10.37 mm2) at 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month', 'description': 'Malapposition is determined by measuring of the distance from the center of blooming to the nearby endoluminal surface of the intima. Malapposition is defined as a measured distance than the total thickness of the stent metal plus polymer of the stent (greater than 200 µm). Malapposition was considered persistent, since was already present at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with persistent stent malapposition at 3 months'}, {'type': 'SECONDARY', 'title': '12-month Persistent Stent Malapposition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Optical Coherence Tomography', 'description': 'Patients who have undergone clinically-indicated PCI of LM where OCT was performed as part of the routine index procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 month', 'description': 'Malapposition is determined by measuring of the distance from the center of blooming to the nearby endoluminal surface of the intima. Malapposition is defined as a measured distance than the total thickness of the stent metal plus polymer of the stent (greater than 200 µm). Malapposition was considered persistent, since was already present at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data analyzed at 12 months.\n\n1 out of 2 participants analyzed had malapposition at 12-month.'}, {'type': 'SECONDARY', 'title': 'Major Adverse Cardiac Event (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MACE', 'description': 'Participants who have undergone clinically-indicated PCI of LM where OCT was performed as part of the routine index procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'MACE reported at 12 months', 'description': 'MACE include:\n\n* Death\n* Myocardial infarction\n* Stroke (cerebrovascular accident or CVA)\n* Urgent revascularization\n* Repeat revascularization\n* Bleeding\n* Stent thrombosis\n* Rehospitalization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with MACE reported at 12 months.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Optical Coherence Tomography', 'description': 'Patients who have undergone clinically-indicated PCI of LM where OCT was performed as part of the routine index procedure will be approached for the study and enrolled if eligible.\n\nOptical Coherence Tomography: OCT will be performed with the St. Jude OCT system.\n\nDetection of metallic stent struts will be performed automatically with manual adjustments made as necessary. Stent area tracings will be automatically performed by interpolated contours connecting the center point of the luminal surface of each detected metallic strut. Stent expansion will be determined as the minimum stent area divided by the average reference lumen area and presented as a percentage. Neo-intimal hyperplasia (NIH) area will be determined in follow-up examinations as the area between the stent and lumen contours. Incomplete stent apposition (ISA) area will be determined as the area between the stent contour and the lumen contour at the site of malapposed struts, in a region not overlying a side branch ostium.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Optical Coherence Tomography', 'description': 'Patients who have undergone clinically-indicated PCI of LM where OCT was performed as part of the routine index procedure will be approached for the study and enrolled if eligible.\n\nOptical Coherence Tomography: OCT will be performed with the St. Jude OCT system.\n\nDetection of metallic stent struts will be performed automatically with manual adjustments made as necessary. Stent area tracings will be automatically performed by interpolated contours connecting the center point of the luminal surface of each detected metallic strut. Stent expansion will be determined as the minimum stent area divided by the average reference lumen area and presented as a percentage. Neo-intimal hyperplasia (NIH) area will be determined in follow-up examinations as the area between the stent and lumen contours. Incomplete stent apposition (ISA) area will be determined as the area between the stent contour and the lumen contour at the site of malapposed struts, in a region not overlying a side branch ostium.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Left Main Coronary Artery stenosis'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-02', 'size': 6957163, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-02-28T12:52', 'hasProtocol': True}, {'date': '2018-01-02', 'size': 183720, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-02-28T12:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Due to lack of enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2018-03-02', 'resultsFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2018-03-14', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-10', 'studyFirstPostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)', 'timeFrame': '3 Months', 'description': 'The stents from 6 participants were analyzed for strut coverage, which is specifically defined as Percentage of Uncovered Stent Struts. The Percentage of Uncovered Stent Struts is the number of struts without distinct overlying tissue, in which the luminal reflection of the strut surface is directly interfacing with the lumen, divided by total number of analyzable struts.'}], 'secondaryOutcomes': [{'measure': 'The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)', 'timeFrame': '12 month', 'description': 'The stents from 2 participants were analyzed for strut coverage, which is specifically defined as Percentage of Uncovered Stent Struts. The Percentage of Uncovered Stent Struts is the number of struts without distinct overlying tissue, in which the luminal reflection of the strut surface is directly interfacing with the lumen, divided by total number of analyzable struts.'}, {'measure': '3-month Persistent Stent Malapposition', 'timeFrame': '3 month', 'description': 'Malapposition is determined by measuring of the distance from the center of blooming to the nearby endoluminal surface of the intima. Malapposition is defined as a measured distance than the total thickness of the stent metal plus polymer of the stent (greater than 200 µm). Malapposition was considered persistent, since was already present at baseline.'}, {'measure': '12-month Persistent Stent Malapposition', 'timeFrame': '12 month', 'description': 'Malapposition is determined by measuring of the distance from the center of blooming to the nearby endoluminal surface of the intima. Malapposition is defined as a measured distance than the total thickness of the stent metal plus polymer of the stent (greater than 200 µm). Malapposition was considered persistent, since was already present at baseline.'}, {'measure': 'Major Adverse Cardiac Event (MACE)', 'timeFrame': 'MACE reported at 12 months', 'description': 'MACE include:\n\n* Death\n* Myocardial infarction\n* Stroke (cerebrovascular accident or CVA)\n* Urgent revascularization\n* Repeat revascularization\n* Bleeding\n* Stent thrombosis\n* Rehospitalization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Percutaneous Coronary Intervention', 'Optical Coherence Tomography', 'In-stent Coronary Artery Restenosis']}, 'descriptionModule': {'briefSummary': 'BACKGROUD:\n\nPercutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis. Protected LM PCI is considered standard of care in most centers.\n\nOCT allows for precise determination of stent placement, stent expansion and apposition. The pattern of vessel healing can be very precisely studied if immediate post-stent implantation OCT/IVUS data is compared to the 6-month post-PCI interval.\n\nWhile OCT cannot be optimally used for ostial lesion imaging, IVUS can be used to image ostial lesions/stent placement.\n\nOptimal and consistent vessel healing is particularly important in LM PCI where stent thrombosis is a potential complication with serious adverse outcome.\n\nHYPOTHESIS:\n\nDue to the absorption of the polymer of the Boston Scientific Synergy Stent over time, early strut coverage patterns and timeline may be different than previously observed in DES and BMS stents in LM PCI. Late acquired stent malapposition (LASM) is expected to differ from previous observations with traditional DES/BMS.\n\nStent coverage in LM PCI will be studied with OCT or IVUS at six and 12 months and compared to OCT or IVUS at the time of stent implantation.\n\nOCT/IVUS data will be analyzed in a core lab (CRF) and correlated with clinical outcomes at 6 and 12 months.', 'detailedDescription': 'The proposed study is a multicenter, observational, prospective, single-arm study of stent strut coverage of patients undergoing LM PCI.\n\nBaseline quantitative coronary analysis (QCA) will be performed at the time of stent implantation.\n\nStent coverage in LM PCI will be studied with OCT at 3 and 12 months and compared to baseline OCT at the time of stent implantation.(31, 32)\n\nOCT/data will be analyzed in a core lab (CTC CRF) and correlated with clinical outcomes at 3 and 12 months.\n\nPrimary Endpoint\n\n• 3-month stent strut coverage in LM PCI\n\nSecondary Endpoints\n\n* 12-month stent strut coverage in LM PCI\n* 3-month late acquired stent malapposition (LASM)\n* 12-month late acquired stent malapposition (LASM)\n* One-month LM Synergy stent safety\n* 1-, 3- and 12-month MACE\n* 1-, 3- and 12-month Stent Thrombosis (ST) (ARC definition)\n\n 75 patients undergoing LM PCI (protected or unprotected) with Boston Scientific Synergy™ stent.\n\nThe goal is to enroll 75 patients from up to 10 VA sites and an enrollment period of 3 years, each site is expected to include 7-10 patients during the study period.\n\nAfter a total of 75 patients are enrolled the study will be closed for further enrollment.\n\nEligible patients will be screened at each participating center and those who had undergone LM PCI with Boston Scientific Synergy™ stent and where OCT was performed during the index procedure will be eligible. The index procedure may be performed by any interventional cardiologist - this is specifically needed in order to maintain equipoise on the part of stent choice and use of OCT.\n\nAt the end of the study enrollment period, the proportion of patients at each site treated with Synergy stents vs. non-Synergy stents and the proportion of patients that underwent OCT imaging during LM PCI will be collected.\n\nEligible patients will be approached and consented for inclusion in the SOLEMN trial after the initial procedure.\n\nStudy Duration\n\nPatients will be followed for 12 months after the index procedure. At one month, clinical follow-up will be performed (clinic or telephone). At 3 months, the angiography and OCT will be performed. At 12 months, the final angiography and OCT will be performed. No further follow-up is planned after completion of the 3- and 12-month angiography and OCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Age 18 years or greater;\n* Left Main CAD, defined as ≥ 50% diameter stenosis and amenable to re-vascularization by PCI;\n* Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.\n* Ability to comply with minimum of 6 months of DAPT after the index procedure.\n* Unprotected Left Main PCI\n* Protected Left Main PCI\n\nExclusion criteria:\n\n* Coexisting conditions that limit life expectancy to less than 12 months or that could affect patient's compliance with the protocol;\n* Serum creatinine greater than 2.0 mg/dL;\n* Cardiogenic shock;\n* STEMI;\n* Non-STEMI, if the cardiac troponin is not stable or starting to decline;\n* Pregnancy;\n* Inability to take dual antiplatelet therapy for 6 months;\n* Any target lesion with previously placed stent.\n* Patients disqualified for CABG surgery.\n* Contraindications for OCT use:\n\n 1. Bacteremia or sepsis\n 2. Major coagulation system abnormalities\n 3. Severe hemodynamic instability or shock\n 4. Patients diagnosed with coronary artery spasm\n 5. Acute renal failure"}, 'identificationModule': {'nctId': 'NCT03474432', 'acronym': 'SOLEMN', 'briefTitle': 'SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI', 'organization': {'class': 'FED', 'fullName': 'Jesse Brown VA Medical Center'}, 'officialTitle': 'SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI', 'orgStudyIdInfo': {'id': 'JBVA-MIV-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Optical Coherence Tomography', 'description': 'Patients who have undergone clinically-indicated PCI of LM where OCT was performed as part of the routine index procedure will be approached for the study and enrolled if eligible.', 'interventionNames': ['Device: Optical Coherence Tomography']}], 'interventions': [{'name': 'Optical Coherence Tomography', 'type': 'DEVICE', 'otherNames': ['Dragonfly OPTIS Imaging Catheter'], 'description': 'OCT will be performed with the St. Jude OCT system. Detection of metallic stent struts will be performed automatically with manual adjustments made as necessary. Stent area tracings will be automatically performed by interpolated contours connecting the center point of the luminal surface of each detected metallic strut. Stent expansion will be determined as the minimum stent area divided by the average reference lumen area and presented as a percentage. Neo-intimal hyperplasia (NIH) area will be determined in follow-up examinations as the area between the stent and lumen contours. Incomplete stent apposition (ISA) area will be determined as the area between the stent contour and the lumen contour at the site of malapposed struts, in a region not overlying a side branch ostium.', 'armGroupLabels': ['Optical Coherence Tomography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham VA Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southern Arizona VA Health Care System', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VA Long Beach Healthcare', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco VA', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'VA Eastern Colorado Health Care System', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30033', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VA Medical Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60025', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Jesse Brown VAMC', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'VA Louis Stokes Cleveland VA Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma City VA Health Care System', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '15240', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'VA Pittsburgh Healthcare System', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29401', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Ralph H. Johnson VA Medical Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78028', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio VA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Mladen I Vidovich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jesse Brown VA Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jesse Brown VA Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine, University of Illinois at Chicago and Chief of Cardiology, Jesse Brown VA Medical Center', 'investigatorFullName': 'Mladen I. Vidovich', 'investigatorAffiliation': 'Jesse Brown VA Medical Center'}}}}