Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-02-08 @ 8:02 AM
Study NCT ID:
NCT06284057
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Silesia Culotte Bifurcation Registry (LSCBR).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-03', 'studyFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Stent thrombosis', 'timeFrame': 'Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)', 'description': 'Stent thrombosis in a stent implanted in a bifurcation during primary intervention. Stent thrombosis was defined according to The Academic Research Consortium-2 consensus document.\n\nThe presence of a thrombus† that originates in the stent/scaffold or in the segment 5 mm proximal or distal to the stent/scaffold or in a side branch originating from the stented/scaffolded segment and the presence of at least 1 of the following criteria:\n\n1)Acute onset of ischemic symptoms at rest 2)New electrocardiographic changes suggestive of acute ischemia 3)Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous myocardial infarction) or Pathological confirmation of stent/scaffold thrombosis'}, {'measure': 'Stent restenosis', 'timeFrame': 'Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)', 'description': 'Stent restenosis in a stent placed in a bifurcation during primary intervention. Stent restenosis should be confirmed by either angiography or intravascular assessment.'}], 'primaryOutcomes': [{'measure': 'Target lesion failure (TLF)', 'timeFrame': 'Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)', 'description': 'The primary endpoint was target lesion failure (TLF): the composite of cardiac death, target vessel myocardial infarction (TVMI), or clinically driven TLR.'}], 'secondaryOutcomes': [{'measure': 'MACE', 'timeFrame': 'Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)', 'description': 'The secondary composed outcome was MACE: myocardial infarction (MI), cardiac death, MB-TLR or/and SB-TLR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous coronary intervention (PCI)', 'Bifurcation lesion', 'Culotte Technique', 'Double Kiss Culotte Technique', 'Acute Coronary Syndrome', 'Two-Stent Technique'], 'conditions': ['Safety Issues', 'Efficacy, Self']}, 'descriptionModule': {'briefSummary': 'The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis.', 'detailedDescription': "The study contains a retrospective analysis of subjects who have undergone PCI in two high-volume cooperative Cardiac Departments in the Lower Silesia Region (Poland) between April 2012 and January 2024. Data regarding all performed PCI from these periods were prescreened in terms of bifurcation lesion with subsequent implantation of two stents using the Culotte technique or the DK-Culotte technique. The indication for percutaneous coronary intervention (PCI) was based either on a judgment made by the Heart Team or on a particular clinical indication (ongoing ischemia, lack of will for the alternative treatment options, presence of significant angiographic CAD suitable for PCI due to ESC/ESH recommendation). The decision to perform the two-stent technique PCI was left to the operator's dissertation based on clinical and angiographical features. All patients were thoroughly informed about all therapeutic options and PCI-related risks before providing written informed consent for the procedure. There were no clinical or vessel-related exclusion criteria (lesion anatomy, length, tortuosity, severity). However, patients who had undergone PCI with coronary stents prior to the index procedure with respect to the bifurcation lesion studied were excluded from the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study includes a retrospective analysis of subjects who underwent PCI in two cooperative cardiac centers in the Lower Silesia region between April 2012 and January 2024. Data from the participating centers on all PCIs performed during these periods were prescreened for bifurcation lesions with subsequent implantation of two stents using the Culotte technique or the DK-Culotte technique. The indication for percutaneous coronary intervention (PCI) was based on the judgment of the cardiac team or on a specific clinical indication (persistent ischemia, unwillingness to accept alternative treatment options, presence of significant angiographic CAD suitable for PCI). The decision to perform PCI with the two-stent technique was left to the operator's judgment based on clinical and angiographic characteristics.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of significant changes in the coronary bifurcation requiring the implantation of two coronary stents using the Culotte or DK Culotte technique.\n\nExclusion Criteria:\n\n* Patients who underwent PCI with coronary stents prior to the index procedure for the bifurcation lesion studied.'}, 'identificationModule': {'nctId': 'NCT06284057', 'acronym': 'LSCBR', 'briefTitle': 'Lower Silesia Culotte Bifurcation Registry (LSCBR).', 'organization': {'class': 'OTHER', 'fullName': 'Regional Cardiology Center, The Copper Health Centre (MCZ),'}, 'officialTitle': 'Double Kissing (DK) vs Culotte Culotte. Lower Silesia Culotte Bifurcation Registry (LSCBR).', 'orgStudyIdInfo': {'id': 'CopperHealthCentre3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Culotte Group', 'description': 'Data regarding patient with performed PCI- bifurcation with subsequent implantation of two stents using the Culotte technique', 'interventionNames': ['Procedure: Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte']}, {'label': 'Double Kiss (DK) Culotte Group', 'description': 'Data regarding patient with performed PCI- bifurcation with subsequent implantation of two stents using the Double Kiss- Culotte technique. DK-Culotte technique is a variety of classical "Culotte techniques" in which one additional kissing balloon dilation is performed just after SB stenting, and prior to MB stent implantation.', 'interventionNames': ['Procedure: Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte']}], 'interventions': [{'name': 'Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte', 'type': 'PROCEDURE', 'description': 'Patient with CAD and coexisting bifurcation lesion requiring two-stent approach treated with Culotte Technique or Double Kiss (DK) Culotte due to operator distraction.', 'armGroupLabels': ['Culotte Group', 'Double Kiss (DK) Culotte Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59-220', 'city': 'Legnica', 'state': 'Lower Silesian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Mateusz Barycki, M.D', 'role': 'CONTACT', 'email': 'mateusz.barycki@gmail.com', 'phone': '+48767211446'}, {'name': 'Piotr Rola, M.D. Ph.D', 'role': 'CONTACT', 'email': 'piotr.rola@gmail.com', 'phone': '+48767211446'}, {'name': 'Mateusz Barycki, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Piotr Rola, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Cardiology, Provincial Specialized Hospital in Legnica,', 'geoPoint': {'lat': 51.21006, 'lon': 16.1619}}, {'zip': '59-300', 'city': 'Lubin', 'state': 'Lower Silesian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Adrian Włodarczak, Assoc Prof.', 'role': 'CONTACT', 'email': 'wlodarczak.adrian@gmail.com', 'phone': '+48768460300'}, {'name': 'Szymon Włodarczak, MD', 'role': 'CONTACT', 'email': 'wlodarczak.szy@gmail.com', 'phone': '+4876 846 03 00'}, {'name': 'Adrian Włodarczak, Assoc Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Szymon Włodarczak, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Cardiology, The Copper Health Centre (MCZ)', 'geoPoint': {'lat': 51.40089, 'lon': 16.20149}}], 'centralContacts': [{'name': 'Mateusz Barycki, MD', 'role': 'CONTACT', 'email': 'mateusz.barycki@gmail.com', 'phone': '+48767211446'}, {'name': 'Adrian Włodarczak, Assoc. Prof.', 'role': 'CONTACT', 'email': 'adrian.wlodarczak@gmail.com', 'phone': '+48768460300'}], 'overallOfficials': [{'name': 'Adrian Włodarczak, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regional Cardiology Center, The Copper Health Centre (MCZ),'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regional Cardiology Center, The Copper Health Centre (MCZ),', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Adrian Włodarczak', 'investigatorAffiliation': 'Regional Cardiology Center, The Copper Health Centre (MCZ),'}}}}