Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-28 @ 10:41 PM
Study NCT ID:
NCT06131333
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2023-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complex CAD Treated With PCI With DES Implantation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}, {'id': 'D004343', 'term': 'Drug Implants'}], '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'}, {'id': 'D003692', 'term': 'Delayed-Action Preparations'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 980}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesion revascularization (TLR)', 'timeFrame': '12 months', 'description': 'During the 12-month follow-up, the incidence of TLR in patients included in the study will be reported. TLR was defined as revascularization post-stenting within the stent or within the 5-mm borders adjacent to the stent.'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiac events (MACE)', 'timeFrame': '12 month', 'description': 'During the 12-month follow-up, the incidence of MACE in patients included in the study will be assessed. Major adverse cardiac event composed of all-cause death, myocardial infarction (MI), or TLR.'}, {'measure': 'Procedural success', 'timeFrame': 'Peri-procedural', 'description': 'Procedural success was defined as angiographic success in the absence of in-hospital major events including death, MI, need for TLR, stroke, vascular access site complications, and contrast agent nephropathy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complex Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'COMPLEX Registry is an investigator-initiated, retrospective, high-volume Polish single-center clinical registry enrolling 980 consecutive patients with complex coronary artery lesions treated percutaneously between September 2015 and December 2021. All data were collected prospectively as regards the clinical and technical endpoints. The study aimed to assess the safety and efficacy of new-generation, thin-struts DES in patients with complex CAD at long-term clinical follow-up. The primary endpoint of the study was the occurrence of TLR during follow-up. Secondary endpoints were a procedural success and the occurrence of MACE, including all-cause death, MI, or TLR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with symptomatic CAD, including chronic coronary syndromes (CCS) and acute coronary syndromes (ACS), qualified for PCI and meeting the criteria for complex CAD were included in the analysis.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For the inclusion of patients in this study, the complexity of CAD was defined as having at least one of the following characteristics: chronic total occlusion (CTO), lesion length \\>40 mm, severe calcification assessed by angiography or intravascular imaging examination, multivessel PCI during the same intervention, or true bifurcation defined as any lesion involving both the main vessel (MV), proximal or distal and the ostium of the side branch (SB) (Medina 1,1,1; 1,0,1; or 0,1,1).\n\nExclusion Criteria:\n\n* left main stem\n* PCI treated during index procedure;\n* cardiogenic shock,\n* thrombolysis before PCI;\n* 12-month follow-up not available'}, 'identificationModule': {'nctId': 'NCT06131333', 'briefTitle': 'Complex CAD Treated With PCI With DES Implantation.', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Complex Coronary Artery Disease Treated With Percutaneous Coronary Intervention - COMPLEX Registry.', 'orgStudyIdInfo': {'id': '821/23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Complex PCI', 'description': 'All consecutive patients with complex coronary artery disease (CAD) were treated with percutaneous coronary intervention (PCI). The complexity of CAD was defined as having at least one of the following characteristics: chronic total occlusion (CTO), lesion length \\>40 mm, severe calcification assessed by angiography or intravascular imaging examination, multivessel PCI during the same intervention, or true bifurcation defined as any lesion involving both the main vessel (MV), proximal or distal and the ostium of the side branch (SB) (Medina 1,1,1; 1,0,1; or 0,1,1).', 'interventionNames': ['Procedure: Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation']}], 'interventions': [{'name': 'Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation', 'type': 'PROCEDURE', 'description': 'PCI was performed according to the general and local recommendations. The choice of DES among the new generation DES and the decision on procedure optimization belonged to the operator.', 'armGroupLabels': ['Complex PCI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-701', 'city': 'Poznan', 'state': 'Wielkopolska', 'country': 'Poland', 'facility': 'Poznan University of Medical Sciences, Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sylwia Iwanczyk', 'investigatorAffiliation': 'Poznan University of Medical Sciences'}}}}