Actively Recruiting

Age: 18Years +
All Genders
ID06284057

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

Long-term Monitoring

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

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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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Frequently Asked Questions

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