Clinical trial NCT06284057: Lower Silesia Culotte Bifurcation Registry (LSCBR).
Official title: Double Kissing (DK) vs Culotte Culotte. Lower Silesia Culotte Bifurcation Registry (LSCBR).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Safety Issues
Efficacy, Self
Keywords: Percutaneous coronary intervention (PCI)
Bifurcation lesion
Culotte Technique
Double Kiss Culotte Technique
Acute Coronary Syndrome
Two-Stent Technique
Lead sponsor: Regional Cardiology Center, The Copper Health Centre (MCZ),
Sponsor class: OTHER
Collaborators: name: Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.
First posted: 2024-02-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Presence of significant changes in the coronary bifurcation requiring the implantation of two coronary stents using the Culotte or DK Culotte technique.

Exclusion Criteria:

* Patients who underwent PCI with coronary stents prior to the index procedure for the bifurcation lesion studied.

Primary outcomes:
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)
Secondary outcomes:
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)
Other outcomes:
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)
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)
Locations:
city: Legnica
country: Poland
facility: Department of Cardiology, Provincial Specialized Hospital in Legnica,
state: Lower Silesia
city: Lubin
country: Poland
facility: Department of Cardiology, The Copper Health Centre (MCZ)
state: Lower Silesia
Study officials:
affiliation: Regional Cardiology Center, The Copper Health Centre (MCZ),
name: Adrian Włodarczak, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: