Actively Recruiting
Double Kissing (DK) vs Culotte Technique for Coronary Bifurcation Lesions Lower Silesia Culotte Bifurcation Registry (LSCBR)
Led by Regional Cardiology Center, The Copper Health Centre (MCZ), · Updated on 2024-03-06
400
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Regional Cardiology Center, The Copper Health Centre (MCZ),
Lead Sponsor
D
Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are analyzing outcomes from patients who underwent percutaneous coronary intervention (PCI) for coronary artery disease involving bifurcation lesions. The study compares two different two-stent techniques: the Culotte technique and the Double Kiss (DK) Culotte technique. This retrospective study uses data collected from two high-volume cardiac centers in the Lower Silesia Region between April 2012 and January 2024. The choice of which stent technique to use was made by the treating physician based on clinical and angiographic factors, with no restrictions on lesion characteristics. Patients included had bifurcation lesions treated with either the classical Culotte technique or the DK-Culotte technique, which involves an additional balloon dilation step after side branch stenting. The study groups consist of patients treated with one of these two stenting methods. The PCI was performed following standard clinical indications, with all patients informed about treatment options and risks before consenting. Patients who had previous stenting of the same bifurcation lesion before the procedure were excluded. Participants' outcomes are monitored retrospectively over a 5-year period following their initial hospital stay. The primary outcome measured is target lesion failure, with evaluations every 6 months after hospital discharge. Secondary outcomes include major adverse cardiac events (MACE). This long-term follow-up allows researchers to assess the safety and effectiveness of the two-stent techniques over time using clinical records and data analysis.
CONDITIONS
Brief Title
Lower Silesia Culotte Bifurcation Registry (LSCBR).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of significant changes in the coronary bifurcation requiring the implantation of two coronary stents using the Culotte or DK Culotte technique.
You will not qualify if you...
- Patients who underwent PCI with coronary stents prior to the index procedure for the bifurcation lesion studied.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure during hospitalization
Participants undergo percutaneous coronary intervention (PCI) involving the implantation of two stents using either the Culotte Technique or the Double Kiss (DK) Culotte Technique based on the operator's decision.
1 hospital visit for the PCI procedure
Duration - Up to 5 years after the initial hospitalization
Participants are monitored for clinical outcomes such as target lesion failure and major adverse cardiac events with follow-up evaluations continuing every 6 months up to 5 years after the initial hospitalization.
Follow-up visits every 6 months for up to 5 years
Trial Site Locations
Total: 2 locations
1
Department of Cardiology, Provincial Specialized Hospital in Legnica,
Legnica, Lower Silesian Voivodeship, Poland, 59-220
Actively Recruiting
2
Department of Cardiology, The Copper Health Centre (MCZ)
Lubin, Lower Silesian Voivodeship, Poland, 59-300
Actively Recruiting
Research Team
M
Mateusz Barycki, MD
A
Adrian Włodarczak, Assoc. Prof.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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