NCT Number: NCT06284057
The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis.
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All sexes
Observational
Department of Cardiology, Provincial Specialized Hospital in Legnica,, Legnica, Lower Silesian Voivodeship, Poland
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient with CAD and coexisting bifurcation lesion requiring two-stent approach treated with Culotte Technique or Double Kiss (DK) Culotte due to operator distraction.
Time frame: 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)
The primary endpoint was target lesion failure (TLF): the composite of cardiac death, target vessel myocardial infarction (TVMI), or clinically driven TLR.
Time frame: 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)
The secondary composed outcome was MACE: myocardial infarction (MI), cardiac death, MB-TLR or/and SB-TLR
Time frame: 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)
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.
The 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:
1)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
Time frame: 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)
Stent restenosis in a stent placed in a bifurcation during primary intervention. Stent restenosis should be confirmed by either angiography or intravascular assessment.
Contact information is provided by the study sponsor or research team.
Adrian Włodarczak, Assoc. Prof.
CONTACT
Mateusz Barycki, MD
CONTACT
Regional Cardiology Center, The Copper Health Centre (MCZ),
Other
Double Kissing (DK) vs Culotte Culotte. Lower Silesia Culotte Bifurcation Registry (LSCBR).
Acronym: LSCBR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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